Public Assessment Report. Decentralised Procedure

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Public Assessment Report. Decentralised Procedure"

Transcription

1 Public Assessment Report Decentralised Procedure Paracetamol 500 mg effervescent tablets Procedure No: UK/H/5662/ /DC UK Licence No: PL 36390/ Cipla (EU) Limited

2 Lay Summary Paracetamol 500 mg effervescent tablets (paracetamol) This is a summary of the public assessment report (PAR) for Paracetamol 500 mg and 1000 mg effervescent tablets (PL 36390/ ; UK/H/5662/ /DC). It explains how Paracetamol 500 mg and 1000 mg effervescent tablets were assessed and their authorisation recommended, as well as their conditions of use. It is not intended to provide practical advice on how to use Paracetamol 500 mg and 1000 mg effervescent tablets. For practical information about using Paracetamol 500 mg and 1000 mg effervescent tablets, patients should read the package leaflet or contact their doctor or pharmacist. What are Paracetamol 500 mg and 1000 mg effervescent tablets and what are they used for? Paracetamol 500 mg effervescent tablets are a generic medicine. This means that they are similar to a reference medicine, already authorised in the European Union (EU) called Panadol Soluble 500 mg Tablets (PL 00071/0072R). Paracetamol 500 mg effervescent tablets are used to relieve mild to moderate pain and/or fever such as headache, migraine, neuralgia, toothache, period pain, rheumatic aches and pains, sore throat and the symptoms of colds and flu in adults and adolescents aged 12 years and above. are a hybrid medicine. This means that they are similar to a reference medicine, already authorised in the European Union (EU) called Panadol Soluble 500 mg Tablets (PL 00071/0072R) that contain the same active substance but are available as a different strength: there is 1000 mg paracetamol in Paracetamol 1000 mg effervescent tablets but there is only 500 mg paracetamol in Panadol Soluble 500 mg Tablets. are used to relieve mild to moderate pain and/or fever such as headache, migraine, neuralgia, toothache, period pain, rheumatic aches and pains, sore throat and the symptoms of colds and flu in adults and adolescents aged 16 years and above. How do Paracetamol 500 mg and 1000 mg effervescent tablets work? Paracetamol 500 mg and 1000 mg effervescent tablets contain the active substance paracetamol. Paracetamol is an analgesic and antipyretic, which relieves aches and reduces fever by a mechanism of action that is believed to be mediated through blocking a signalling pathway within the central nervous system. How are Paracetamol 500 mg and 1000 mg effervescent tablets used? One Paracetamol 500 mg or 1000 mg effervescent tablet should be placed in a full glass of water. Once completely dissolved, the patient should drink the solution straight away. Paracetamol 500 mg effervescent tablets In adolescents of 12 to 15 years and weighing 41 to 50 kg the usual dose is one Paracetamol 500 mg effervescent tablet, repeated every 4-6 hours if necessary. The patient should not take more than 4 tablets (2000 mg paracetamol) in 24 hours. In adults and adolescents aged 16 years and older, weighing more than 50 kg, the usual dose is one to two Paracetamol 500 mg effervescent tablets, repeated every 6 hours as needed. The patient should not take more than 8 tablets (4000 mg paracetamol) in 24 hours. 2

3 In adults and adolescents aged 16 years and older, weighing less than 50 kg, the usual dose is one Paracetamol 500 mg effervescent tablet, repeated every 6 hours as needed. The maximum daily dose should not exceed 60 mg per kg of bodyweight; i.e. this would be up to a maximum of 4 tablets (2000 mg paracetamol) in 24 hours. In adults and adolescents aged 16 years and older, weighing more than 50 kg, the usual dose is one Paracetamol 1000 mg effervescent tablet, repeated every 6 hours as needed. The patient should not take more than 4 tablets (4000 mg paracetamol) in 24 hours. In patients with kidney or liver problems the dose should be decreased. The 1000 mg tablet should not, however, be divided into two equal doses to achieve a lower dose; Paracetamol tablets of lower strengths are available on the market to achieve a lower dose. Please read Section 3 of the package leaflet for detailed information on dosing recommendations, the route of administration and the duration of treatment. Paracetamol 500 mg and 1000 mg effervescent tablets can be obtained without a prescription. What benefits of Paracetamol 500 mg and 1000 mg effervescent tablets have been shown in studies? Because Paracetamol 500 mg effervescent tablets are a generic medicine, studies in patients have been limited to determine that they are bioequivalent to the reference medicine, Panadol Soluble 500 mg Tablets. Two medicines are bioequivalent when they produce the same levels of the active substance in the body. are in the form of an oral solution at the time of administration and contain the active substance, paracetamol, in the same concentration as a dose of two Paracetamol 500 mg effervescent tablets. It is considered that one Paracetamol 1000 mg effervescent tablet will be bioequivalent to two Paracetamol 500 mg effervescent tablets. What are the possible side effects from Paracetamol 500 mg and 1000 mg effervescent tablets? Like all medicines, these medicines can cause side effects, although not everybody gets them. For information about side effects that may occur when using Paracetamol 500 mg and 1000 mg effervescent tablets, please refer to the package leaflets or the Summaries of Product Characteristics (SmPCs) available on the Medicines and Healthcare products Regulatory Agency website. For a full list of restrictions, see the package leaflets. Why are Paracetamol 500 mg and 1000 mg effervescent tablets approved? The MHRA decided that the benefits of Paracetamol 500 mg and 1000 mg effervescent tablets outweigh the identified risks and it was recommended that they be approved for use. 3

4 What measures are being taken to ensure the safe and effective use of Paracetamol 500 mg and 1000 mg effervescent tablets? A Risk Management Plan (RMP) has been developed to ensure that Paracetamol 500 mg and 1000 mg effervescent tablets are used as safely as possible. Based on this plan, safety information has been included in the Summaries of Product Characteristics (SmPCs) and the package leaflets for Paracetamol 500 mg and 1000 mg effervescent tablets, including the appropriate precautions to be followed by healthcare professionals and patients. Known side effects are continuously monitored. Furthermore, new safety signals reported by patients and healthcare professionals will be monitored and reviewed continuously as well. Other information about Paracetamol 500 mg and 1000 mg effervescent tablets Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Romania, Spain (1000 mg strength only), the Slovak Republic, Slovenia, Sweden and the UK agreed to grant Marketing Authorisations to Cipla (EU) Limited for Paracetamol 500 mg and 1000 mg effervescent tablets on 24 June The Marketing Authorisations in the UK were granted on 24 July The full PAR for Paracetamol 500 mg and 1000 mg effervescent tablets follows this summary. For more information about taking Paracetamol 500 mg and 1000 mg effervescent tablets, read the package leaflets or contact your doctor or pharmacist. This summary was last updated in October

5 Table of Contents I Introduction Page 6 II Quality aspects Page 8 III Non-clinical aspects Page 10 IV Clinical aspects Page 10 V User consultation Page 22 VI Overall conclusion, benefit/risk assessment and recommendation Page 23 Table of content of the PAR update for MRP and DCP Page 30 5

6 I Introduction Based on the review of the data on quality, safety and efficacy, the Member States have granted Marketing Authorisations (MAs) for the medicinal products Paracetamol 500 mg and 1000 mg effervescent tablets. Paracetamol 500 mg effervescent tablets are a general sales list medicine (legal status GSL), indicated for the symptomatic treatment of mild to moderate pain and/or fever in adults and adolescents aged 12 years and above. Owing to the GSL legal supply status in the UK, the marketing of Paracetamol 500 mg effervescent tablets is limited to a maximum of 30 tablets. are a pharmacy medicine (legal status P), indicated for the short term symptomatic treatment of mild to moderate pain and/or fever in adults and adolescents aged 16 years and above. These applications were submitted using the Decentralised Procedure (DCP), with the UK as Reference Member State (RMS) and Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic, Denmark, Estonia, Finland, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Romania, Spain (1000 mg strength only), the Slovak Republic, Slovenia and Sweden as Concerned Member States (CMSs). The application for Paracetamol 500 mg effervescent tablets was made under Article 10(1) of Directive 2001/83/EC, as amended, as a generic medicinal product (). The reference medicinal product, which has been authorised in accordance with Community provisions in force for not less than 10 years in the European Economic Area (EEA), is Panadol Soluble 500 mg Tablets (PL 00071/0072R). This product was authorised to SmithKline Beecham (SWG) Limited in the UK on 12 January The application for was made under Article 10(1) of Directive 2001/83/EC, as amended, as a generic medicinal product in Ireland and Spain on the basis of the existence of reference products from the GSK / Smithkline Beecham family for paracetamol 1000 mg effervescent tablets. In all the other member states, including the UK, the application for was submitted under Article 10(3) of Directive 2001/83/EC, as amended, as it is a new strength. Consequently, in accordance with the Coordination of Mutual Recognition and Decentralised procedures (CDMh) guidance (CMDh/089/2002) the overall legal basis for the 1000 mg strength () is Article 10. The active substance in Paracetamol 500 mg and 1000 mg effervescent tablets is paracetamol. Paracetamol is one of the most commonly used drugs for the safe and effective treatment of pain and fever. Paracetamol works by lowering cyclo-oxygenase products preferentially in the central nervous system, where oxidant stress is strictly limited. However, the precise mechanism of action for paracetamol on cyclo-oxygenase activity is not known. No new non-clinical studies were conducted, which is acceptable given that these applications are based on being generic and hybrid medicinal products of an originator product that has been licensed for over 10 years. Since Paracetamol 500 mg and 1000 mg effervescent tablets are intended to be used in place of other similar products, this will not lead to an increased exposure to the environment. An 6

7 Environmental Risk Assessment (ERA) is, therefore, not deemed necessary. With the exception of a bioequivalence study, no new clinical data were provided with these applications. One bioequivalence study was performed, which compared the pharmacokinetics of the applicant s Paracetamol 500 mg effervescent tablets with those of the reference product, Panadol Soluble 500 mg Tablets, in healthy subjects under fasting conditions. It is stated by the applicant that the study was conducted in accordance with the Declaration of Helsinki and Good Clinical Practice (GCP). In accordance with the CHMP Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr**), bioequivalence studies may be waived if the test product is an aqueous oral solution at time of administration and contains an active substance in the same concentration as an approved oral solution. The applicant has requested a biowaiver for as the active is in solution at the time of administration. The RMS has been assured that acceptable standards of Good Manufacturing Practice (GMP) are in place for these product types at all sites responsible for the manufacture, assembly and batch release of these products. For manufacturing sites within the Community, the RMS has accepted copies of current manufacturer authorisations issued by inspection services of the competent authorities as certification that acceptable standards of GMP are in place at those sites. For manufacturing sites outside the Community, the RMS has accepted copies of current GMP Certificates of satisfactory inspection summary reports issued by the inspection services of the MHRA as certification that acceptable standards of GMP are in place at those non-community sites. A Risk Management Plan (RMP) and a summary of the pharmacovigilance system have been provided with these applications and these are satisfactory. The RMS and CMSs considered that the applications could be approved at the end of procedure (Day 210) on 24 June After a subsequent National phase, licences were granted in the UK on 24 July

8 II Quality aspects II.1 Introduction The applications are submitted according to Article 10 of Directive 2001/83/EC, as amended. The applicant has specified Panadol Soluble 500 mg Tablets (PL 00071/0072R) as the reference medicinal product. Paracetamol 500 mg effervescent tablets are formulated as white to off-white, circular, flat-faced, bevelled edge tablets, of diameter mm, debossed with a ring on one side and plain on the other. are formulated as white to off-white, circular, flat-faced, bevelled tablets, of diameter mm, plain on both sides. Each Paracetamol 500 mg and 1000 mg effervescent tablet contains 500 mg and 1000 mg of paracetamol, respectively. The excipients present are: anhydrous citric acid (E330), povidone, sodium bicarbonate (E500), sodium saccharin (E954), anhydrous sodium carbonate (E500), simeticone (E900), polysorbate 80 (E443) and aspartame (E951). Paracetamol 500 mg and 1000 mg effervescent tablets are packaged in 4-ply laminate-glassine paper/polythene/aluminium foil/polythene (PPFP) or 4-ply laminate-glassine paper/polythene/ aluminium foil/surlyn (Surlyn) strips, which are further packed into cardboard cartons of 8, 10, 12, 16, 20, 24, 32, 50, 60, 100 units for Paracetamol 500 mg effervescent tablets and 8, 10, 12, 16, 20, 32, 40, 50, 60, 100 units for Paracetamol 1000 mg effervescent tablets. Owing to the GSL legal supply status of Paracetamol 500 mg effervescent tablets in the UK, pack sizes of this product are limited to a maximum of 30 tablets and, therefore, the maximum approved pack size will be 24 tablets. II.2 Drug Substance Paracetamol INN: Chemical Name: Structure: Paracetamol N-(4-hydroxyphenyl) acetamide. Molecular formula: C 8 H 9 NO 2 Molecular weight: g/mol Appearance: white or almost white, crystalline powder Solubility: sparingly soluble in water, freely soluble in alcohol, very slightly soluble in methylene chloride. Paracetamol is the subject of a European Pharmacopoeia monograph. All aspects of the manufacture and control of the active substance, paracetamol, are covered by European Directorate for the Quality of Medicines and Healthcare (EDQM) Certificates of Suitability. 8

9 II.3 Medicinal Product Pharmaceutical development The objective of pharmaceutical development was to produce an effervescent tablet comparable to the reference product Panadol Soluble 500mg Tablets (PL 00071/0072R). The development of was subsequently based in the Paracetamol 500 mg effervescent tablet. The development of the drug products has been described, the choice of excipients is justified and their functions explained. Comparative disintegration and assay analysis between batches of Paracetamol 500 mg and 1000 mg effervescent tablets and batches of the reference medicinal product, Panadol Soluble 500mg Tablets (PL 00071/0072R) were undertaken. The results were comparable. All the excipients used in the manufacture of the proposed formulation comply with their respective European Pharmacopoeia monographs. Satisfactory certificates of analysis have been provided for all excipients showing compliance with their proposed specifications. None of the excipients are sourced from animal or human origin. No genetically modified organisms (GMO) have been used in the preparation of these products. Manufacture of the product Satisfactory batch formulae have been provided for the manufacture of the finished products, together with an appropriate account of the manufacturing process. Satisfactory process validation was performed for the manufacturing process on six production-scale batches of Paracetamol 500 mg effervescent tablets and five production-scale batches of Paracetamol 1000 mg tablets. Product Specifications The finished product specifications are satisfactory. Satisfactory batch analysis data showing satisfactory compliance with the specifications have been presented. Certificates of analysis have been provided for all working standards used. Stability of the product Stability studies were performed in accordance with current guidelines on at least three batches of each strength of finished product, packed in the packaging proposed for marketing. The data from these studies support a shelf-life of 3 years when stored in the original packaging in order to protect from light and moisture. The solutions are stable up to 8 hours, below 25 C, after dissolving the tablet. Suitable post approval stability commitments have been provided. II.4 Discussion on chemical, pharmaceutical and biological aspects The grant of Marketing Authorisations is recommended for these applications. 9

10 III Non-clinical aspects No new non-clinical studies have been submitted in support of these applications. The pharmacodynamic, pharmacokinetic and toxicological properties of paracetamol are well-known. As paracetamol is a widely used, well-known active substance, the applicant has not provided additional studies and further studies are not required. A satisfactory non-clinical overview, based on a review of the literature, has been supplied. The non-clinical sections of the SmPCs have been updated in line with the QRD template and reflect the information in the reference product SmPC, which is acceptable. There are no objections to approval of Paracetamol 500 mg and 1000 mg effervescent tablets from a non-clinical point of view. Environmental Risk Assessment (ERA) Since Paracetamol 500 mg and 1000 mg effervescent tablets are intended to be used in place of other similar products, this will not lead to an increased exposure to the environment. An ERA is, therefore, not deemed necessary. IV Clinical aspects IV.1 Introduction The applications have been submitted under Article 10 according to Directive 2001/83/EC, as amended. With the exception of bioequivalence data for Paracetamol 500 mg effervescent tablets, no new clinical data was submitted with these applications and none are required. The applicant sought a biowaver of clinical studies for and this was accepted please see Section and IV.2. The applicant s clinical overview has been written by an appropriately qualified person and provides an adequate summary of published literature on the clinical pharmacology, efficacy and safety of paracetamol. This is considered acceptable. IV.2 Pharmacokinetics In support of these applications, the Marketing Authorisation holder has submitted the following bioequivalence study: Bioequivalence study comparing Paracetamol 500 mg effervescent tablets with Panadol Soluble 500 mg tablets in healthy adult human subjects under fasting conditions. This was an open label, randomised, two-treatment, two-period, two-sequence, single dose, crossover, bioequivalence study in healthy adult male human subjects under fasting conditions. The subjects received the test or reference treatment (a single oral dose of one tablet with 240 ml water at room temperature) after an overnight fast of at least 10 hours. Blood samples were taken for the measurement of pharmacokinetic parameters pre-dose and up to 24 hours post-dose. The two treatment periods were separated by a 2-day washout period. 10

11 The main pharmacokinetic results are presented below: TestGeoLSM geometric least square mean for the test product (Paracetamol 500 mg effervescent tablets) RefGeoLSM geometric least square mean for the reference product (Panadol Soluble 500 mg tablets) The 90% confidence intervals were within the acceptance criteria of 80.00% %. Based on these results, the proposed product, Paracetamol 500 mg effervescent tablets, can be considered bioequivalent with the reference product Panadol Soluble 500 mg tablets. The applicant has requested a biowaiver for. According to the EMEA Guideline on the investigation of bioequivalence (CPMP/EWP/QWP/1401/98 Rev. 1/Corr**) bioequivalence studies may be waived if the test product is an aqueous oral solution at time of administration and contains an active substance in the same concentration as an approved oral solution. Paracetamol 1000 mg effervescent tablets are in the form of an aqueous oral solution at the time of administration but there is no approved equivalent effervescent product with the same concentration of active substance. The dissolution profile of has been compared with that of Paracetamol 500 mg effervescent tablets and shown to be comparable, with 100% dissolution achieved in a few minutes. Furthermore, the applicant has provided suitable justification that the excipients do not affect the biopharmaceutical properties of the product. The justification for a biowaver is accepted. IV.3 Pharmacodynamics No new pharmacodynamic data are required and none have been submitted. The applicant s review of the literature in the clinical overview is acceptable. IV.4 Clinical efficacy No new clinical efficacy data are required and none have been submitted. The applicant s review of the literature in the clinical overview is acceptable. IV.5 Clinical safety With the exception of the bioequivalence study, no new data have been provided and none are required for these applications. No serious adverse events were reported during the bioequivalence study. Only one adverse event was reported during the study, which was of mild intensity and not drug-related. 11

12 IV.6 Risk Management Plan (RMP) The marketing authorisation holder has submitted an RMP, in accordance with the requirements of Directive 2001/83/EC as amended, describing the pharmacovigilance activities and interventions designed to identify, characterise, prevent or minimise risks relating to Paracetamol 500 mg and 1000 mg effervescent tablets. A summary of safety concerns and planned risk minimisation activities, as approved in the RMP, are listed below: 12

13 Important identified risks 13

14 14

15 15

16 16

17 17

18 18

19 19

20 20

21 Important potential risk 21

22 Missing information V.7 Discussion on the clinical aspects The grant of Marketing Authorisations is recommended for these applications. V User consultation The patient leaflet for Paracetamol 500 mg effervescent tablets has been evaluated via a user consultation study in accordance with the requirements of Articles 59(3) and 61(1) of Directive 2001/83/EC. The language used for the purpose of user testing the package leaflet was English. 22

23 The results show that the package leaflet meets the criteria for readability as set out in the Guideline on the readability of the label and package leaflet of medicinal products for human use. A user consultation with target patient groups on the PIL for Paracetamol 1000 mg effervescent tablets has been performed on the basis of a bridging report making reference to Paracetamol 500 mg effervescent tablets. The bridging report submitted by the applicant has been found to be acceptable. VI Overall conclusion, benefit/risk assessment and recommendation The quality of the products is acceptable, and no new non-clinical or clinical safety concerns have been identified. The applications contain an adequate review of published clinical data. The test product, Paracetamol 500 mg effervescent tablets, can be considered bioequivalent with the reference product, Panadol Soluble 500 mg tablets. A justification for a biowaver for has been accepted. The benefit/risk assessment is, therefore, considered to be positive. The Summaries of Product Characteristics (SmPCs), package leaflets and labelling are satisfactory, in line with current guidelines and consistent with the reference product. In accordance with Directive 2012/84/EU, the current approved UK versions of the SmPCs and package leaflets for these products are available on the Medicines and Healthcare products Regulatory Agency website. The currently approved labels are listed below: 23

24 24

25 25

26 26

27 27

28 28

29 29

30 Table of content of the PAR update for MRP and DCP Steps taken after the initial procedure with an influence on the Public Assessment Report (Type II variations, PSURs, commitments) Scope Procedure number Product information affected Date of start of the procedure Date of end of procedure Approval/ non approval Assessment report attached Y/N (version) 30

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure Amlodipine Pfizer 5 mg tablets Amlodipine Pfizer 10 mg tablets Amlodipine Pfizer 5 mg hard capsules Amlodipine Pfizer 10 mg hard capsules Procedure No:

More information

Public Assessment Report UKPAR. Levonorgestrel 1.5 mg tablet. (levonorgestrel). UK Licence No: PL 41947/0006. ELC Group s.r.o.

Public Assessment Report UKPAR. Levonorgestrel 1.5 mg tablet. (levonorgestrel). UK Licence No: PL 41947/0006. ELC Group s.r.o. Public Assessment Report UKPAR Levonorgestrel 1.5 mg tablet (levonorgestrel). UK Licence No: PL 41947/0006 ELC Group s.r.o. 1 LAY SUMMARY Levonorgestrel 1.5 mg tablet (Levonorgestrel, tablet, 1.5 mg) This

More information

Public Assessment Report. Decentralised Procedure

Public Assessment Report. Decentralised Procedure Public Assessment Report Decentralised Procedure LANSOPRAZOLE 15 MG AND 30 MG ORODISPERSIBLE TABLETS (lansoprazole) Procedure No: UK Licence No: PL 35507/0118-0119 Lupin (Europe) Limited LAY SUMMARY Lansoprazole

More information

Public Assessment Report. Scientific discussion. Desloracell 5 mg, film-coated tablet. (desloratadine) NL License RVG: 112807

Public Assessment Report. Scientific discussion. Desloracell 5 mg, film-coated tablet. (desloratadine) NL License RVG: 112807 Public Assessment Report Scientific discussion Desloracell 5 mg, film-coated tablet (desloratadine) NL License RVG: 112807 Date: 6 July 2015 This module reflects the scientific discussion for the approval

More information

Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044

Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044 Levonorgestrel/Ethinylestradiol 150/30 Microgram Coated Tablets PL 20117/0044 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 11 Summary of Product

More information

Public Assessment Report. Scientific discussion

Public Assessment Report. Scientific discussion Public Assessment Report Scientific discussion 1) Risedronat Actavis 5 mg Filmtabletten, 30 mg Filmtabletten, 35 mg einmal wöchentlich Filmtabletten 2) Bifodron 5 mg Filmtabletten, 30 mg Filmtabletten,

More information

Compilation of individual product-specific guidance on demonstration of bioequivalence

Compilation of individual product-specific guidance on demonstration of bioequivalence 17 December 2014 EMA/CHMP/736403/2014 Committee for Medicinal Products for Human Use (CHMP) Compilation of individual product-specific guidance on demonstration of bioequivalence Initial batch of individual

More information

COMMUNICATION FROM THE COMMISSION

COMMUNICATION FROM THE COMMISSION EUROPEAN COMMISSION Brussels, 17.9.2014 C(2014) 6767 final COMMUNICATION FROM THE COMMISSION Updating of data used to calculate lump sum and penalty payments to be proposed by the Commission to the Court

More information

Public Assessment Report. Scientific discussion. Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets. (pantoprazole) NL/H/2751/001-002/DC

Public Assessment Report. Scientific discussion. Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets. (pantoprazole) NL/H/2751/001-002/DC Public Assessment Report Scientific discussion Pantoprazol Beximco 20 mg and 40 mg, gastro-resistant tablets (pantoprazole) NL/H/2751/001-002/DC Date: 27 August 2014 This module reflects the scientific

More information

List of nationally authorised medicinal products

List of nationally authorised medicinal products 9 July 2015 EMA/483660/2015 Procedure Management and Committees Support Active substance: diphtheria, tetanus, pertussis (acellular, component), poliomyelitis (inactivated), haemophilus type b conjugate

More information

UKPAR Goodnight THR 00904/0003. Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS. Lay Summary Page 2. Scientific discussion Page 3

UKPAR Goodnight THR 00904/0003. Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS. Lay Summary Page 2. Scientific discussion Page 3 Goodnight THR 00904/0003 UKPAR TABLE OF CONTENTS Lay Summary Page 2 Scientific discussion Page 3 Steps taken for assessment Page 12 Steps taken after authorisation Page 13 Summary of Product Characteristics

More information

Planned Healthcare in Europe for Lothian residents

Planned Healthcare in Europe for Lothian residents Planned Healthcare in Europe for Lothian residents Introduction This leaflet explains what funding you may be entitled to if you normally live in Lothian (Edinburgh, West Lothian, Midlothian and East Lothian

More information

EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond

EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond EDQM Certificates of Suitability: Cooperation Among Inspectorates in Europe And Beyond 14 th International Conference of Drug Regulatory Authorities Pre-ICDRA Meeting Dr Susanne Keitel European Directorate

More information

Volume 2B Notice to Applicants. Medicinal products for human use. Presentation and format of the dossier. Common Technical Document (CTD)

Volume 2B Notice to Applicants. Medicinal products for human use. Presentation and format of the dossier. Common Technical Document (CTD) Volume 2B Notice to Applicants Medicinal products for human use Presentation and format of the dossier Common Technical Document (CTD) Introduction Edition June 26 Module 1 Edition May 28 Module 2 Edition

More information

ERASMUS+ MASTER LOANS

ERASMUS+ MASTER LOANS ERASMUS+ MASTER LOANS Erasmus+ Master Loan: opening up access to more affordable lending for cross-border studies The Erasmus+ programme makes it possible for students who want to take a full Masters level

More information

Labour Force Survey 2014 Almost 10 million part-time workers in the EU would have preferred to work more Two-thirds were women

Labour Force Survey 2014 Almost 10 million part-time workers in the EU would have preferred to work more Two-thirds were women 75/2015-27 April 2015 Labour Force Survey 2014 Almost 10 million part-time workers in the EU would have preferred to work more Two-thirds were women Among the 44.1 million persons in the European Union

More information

Alcohol Consumption in Ireland 1986-2006 A Report for the Health Service Executive

Alcohol Consumption in Ireland 1986-2006 A Report for the Health Service Executive Alcohol Consumption in Ireland 1986-2006 A Report for the Health Service Executive Prepared by Dr. Ann Hope This report should be referenced: Hope, A. (2007). Alcohol consumption in Ireland 1986-2006.

More information

CENTRAL BANK OF CYPRUS

CENTRAL BANK OF CYPRUS APPENDIX 2 NOTIFICATION BY A BANK INCORPORATED IN CYPRUS, WHICH WISHES TO PROVIDE SERVICES, ON A CROSS BORDER BASIS, IN OTHER EUROPEAN UNION (E.U.) MEMBER STATES IN ACCORDANCE WITH ARTICLE (28) OF THE

More information

Challenges in Combating Pensioner Poverty Helsinki, 4-5 Dec 2006

Challenges in Combating Pensioner Poverty Helsinki, 4-5 Dec 2006 Challenges in Combating Pensioner Poverty Helsinki, 4-5 Dec 2006 1st Afternoon Plenary session Design and reform of minimum income guarantee and general public earnings related pension schemes and their

More information

SURVEY ON THE TRAINING OF GENERAL CARE NURSES IN THE EUROPEAN UNION. The current minimum training requirements for general care nurses

SURVEY ON THE TRAINING OF GENERAL CARE NURSES IN THE EUROPEAN UNION. The current minimum training requirements for general care nurses SURVEY ON THE TRAINING OF GENERAL CARE NURSES IN THE EUROPEAN UNION This survey serves as a background document for the discussion of the Commission's legislative proposal to modernize the minimum requirements

More information

1. Perception of the Bancruptcy System... 2. 2. Perception of In-court Reorganisation... 4

1. Perception of the Bancruptcy System... 2. 2. Perception of In-court Reorganisation... 4 Bankruptcy Systems and In-court Reorganisation of Firms, 2010 Content: 1. Perception of the Bancruptcy System... 2 2. Perception of In-court Reorganisation... 4 3. Perception of Creditor Committees, Fast

More information

- Assessment of the application by Member States of European Union VAT provisions with particular relevance to the Mini One Stop Shop (MOSS) -

- Assessment of the application by Member States of European Union VAT provisions with particular relevance to the Mini One Stop Shop (MOSS) - - Assessment of the application by Member States of European Union VAT provisions with particular relevance to the Mini One Stop Shop (MOSS) - BACKGROUND The information available on this website relates

More information

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT

FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT FRENCH AGENCY FOR VETERINARY MEDICINAL PRODUCTS DECENTRALISED PROCEDURE FOR A VETERINARY MEDICINAL PRODUCT VIRBAKOR 20 mg film-coated tablet for dogs Date: 03/11/2014 French agency for food, environnemental

More information

ERASMUS+ MASTER LOANS

ERASMUS+ MASTER LOANS Ref. Ares(2015)660570-17/02/2015 ERASMUS+ MASTER LOANS Erasmus+ Master Loan: opening up access to more affordable lending for cross-border studies The Erasmus+ programme makes it possible for students

More information

Agencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State)

Agencia Española de Medicamentos y Productos Sanitarios C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DEPARTAMENTO DE MEDICAMENTOS VETERINARIOS Medicamentos y Productos C/Campezo 1, Edificio 8 28022 Madrid España (Reference Member State) DECENTRALISED PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR

More information

A critical review of the current. marketing authorisation transfer procedure. in Europe

A critical review of the current. marketing authorisation transfer procedure. in Europe A critical review of the current marketing authorisation transfer procedure in Europe Wissenschaftliche Prüfungsarbeit zur Erlangung des Titels Master of Drug Regulatory Affairs der Mathematisch-Naturwissenschaftlichen

More information

YOUNG PEOPLE AND DRUGS

YOUNG PEOPLE AND DRUGS Eurobarometer YOUNG PEOPLE AND DRUGS REPORT Fieldwork: June 2014 Publication: August 2014 This survey has been requested by the European Commission, Directorate-General for Justice and co-ordinated by

More information

EUROPEAN CITIZENS DIGITAL HEALTH LITERACY

EUROPEAN CITIZENS DIGITAL HEALTH LITERACY Flash Eurobarometer EUROPEAN CITIZENS DIGITAL HEALTH LITERACY REPORT Fieldwork: September 2014 Publication: November 2014 This survey has been requested by the European Commission, Directorate-General

More information

INNOBAROMETER 2015 - THE INNOVATION TRENDS AT EU ENTERPRISES

INNOBAROMETER 2015 - THE INNOVATION TRENDS AT EU ENTERPRISES Eurobarometer INNOBAROMETER 2015 - THE INNOVATION TRENDS AT EU ENTERPRISES REPORT Fieldwork: February 2015 Publication: September 2015 This survey has been requested by the European Commission, Directorate-General

More information

EUF STATISTICS. 31 December 2013

EUF STATISTICS. 31 December 2013 . ESTIMATES OF EU TURNOVER VOLUMES. Turnover volumes by product, allocation and notification (Estimates of EU s, Millions of ) Estimate of the EU % on Turnover Significance of the sample on total turnover

More information

Public Assessment Report. Scientific discussion. Atorvastatine Glob 10 mg,20 mg, 40 mg, and 80 mg, film-coated tablets

Public Assessment Report. Scientific discussion. Atorvastatine Glob 10 mg,20 mg, 40 mg, and 80 mg, film-coated tablets Public Assessment Report Scientific discussion Atorvastatine Glob 10 mg,20 mg, 40 mg, and 80 mg, film-coated tablets (Atorvastatin calcium trihydrate) NL/H/2994/001-004/DC Date: 16 March 2015 This module

More information

193/2014-15 December 2014. Hourly labour costs in the EU28 Member States, 2012 (in )

193/2014-15 December 2014. Hourly labour costs in the EU28 Member States, 2012 (in ) 193/2014-15 December 2014 Labour Cost Survey 2012 in the EU28 Labour costs highest in the financial and insurance sector Three times higher than in the accommodation and food sector In 2012, average hourly

More information

Health care in Scotland for UK passport holders living abroad

Health care in Scotland for UK passport holders living abroad Health care in Scotland for UK passport holders living abroad If you have a UK passport and you live abroad, this factsheet tells you how you can get health care from the NHS when you are in Scotland.

More information

187/2014-5 December 2014. EU28, euro area and United States GDP growth rates % change over the previous quarter

187/2014-5 December 2014. EU28, euro area and United States GDP growth rates % change over the previous quarter 187/2014-5 December 2014 This News Release has been revised following an error in the data for Gross Fixed Capital Formation. This affects both the growth of GFCF and its contribution to GDP growth. All

More information

Regulatory approval routes in the European System for Medicinal Products

Regulatory approval routes in the European System for Medicinal Products Regulatory approval routes in the European System for Medicinal Products Cardiovascular Combination Pharmacotherapy Global Summit, Melbourne, 8 th May 2014 Presented by: Kevin Blake Human Medicines Research

More information

Car tax refund on export

Car tax refund on export Car tax customer bulletin 13 Car tax refund on export www.tulli.fi 1 January 2015 Replaces the bulletin from August 2014 Car tax refund on export This bulletin applies to getting refund on export if a

More information

99/2015-9 June 2015. EU28, euro area and United States GDP growth rates % change over the previous quarter

99/2015-9 June 2015. EU28, euro area and United States GDP growth rates % change over the previous quarter 2005Q1 2005Q2 2005Q3 2005Q4 2006Q1 2006Q2 2006Q3 2006Q4 2007Q1 2007Q2 2007Q3 2007Q4 2008Q1 2008Q2 2008Q3 2008Q4 2009Q1 2009Q2 2009Q3 2009Q4 2010Q1 2010Q2 2010Q3 2010Q4 2011Q1 2011Q2 2011Q3 2011Q4 2012Q1

More information

Public Assessment Report Scientific discussion. Tostrex (Testosterone) SE/H/571/01

Public Assessment Report Scientific discussion. Tostrex (Testosterone) SE/H/571/01 Public Assessment Report Scientific discussion Tostrex (Testosterone) SE/H/571/01 This module reflects the scientific discussion for the approval of Tostrex. The procedure was finalised at 2006-04-07.

More information

The coordination of healthcare in Europe

The coordination of healthcare in Europe The coordination of healthcare in Europe Rights of insured persons and their family members under Regulations (EC) No 883/2004 and (EC) No 987/2009 Social Europe European Commission The coordination of

More information

Product name Strength Pharmaceutical form. 100/6 micrograms per actuation. Formodual 100/6 Mikrogramm/Sprüh stoß, Druckgasinhalation, Lösung

Product name Strength Pharmaceutical form. 100/6 micrograms per actuation. Formodual 100/6 Mikrogramm/Sprüh stoß, Druckgasinhalation, Lösung Annex I List of the names, pharmaceutical, strength of the medicinal products, route of, marketing authorisation holders in the member states 1 Belgium Bulgaria Cyprus Denmark Estonia Finland 100/6 Mikrogramm/Sprüh

More information

2 ND CALL FOR PROPOSALS 27 October 2008 30 January 2009

2 ND CALL FOR PROPOSALS 27 October 2008 30 January 2009 2 ND CALL FOR PROPOSALS 27 October 2008 30 January 2009 1. INTRODUCTION Authorities and stakeholders at local and regional level have a vital role to play in the achievement of the EU s strategies for

More information

Family benefits Information about health insurance country. Udbetaling Danmark Kongens Vænge 8 3400 Hillerød. A. Personal data

Family benefits Information about health insurance country. Udbetaling Danmark Kongens Vænge 8 3400 Hillerød. A. Personal data Mail to Udbetaling Danmark Kongens Vænge 8 3400 Hillerød Family benefits Information about health insurance country A. Personal data Name Danish civil registration (CPR) number Address Telephone number

More information

Energy prices in the EU Household electricity prices in the EU rose by 2.9% in 2014 Gas prices up by 2.0% in the EU

Energy prices in the EU Household electricity prices in the EU rose by 2.9% in 2014 Gas prices up by 2.0% in the EU 92/2015-27 May 2015 Energy prices in the EU Household electricity prices in the EU rose by 2.9% in 2014 Gas prices up by 2.0% in the EU In the European Union (EU), household electricity prices 1 rose by

More information

Transparency Directive 2. Are you ready? Darren Fox 25 June 2015

Transparency Directive 2. Are you ready? Darren Fox 25 June 2015 Transparency Directive 2 Are you ready? Darren Fox 25 June 2015 Introduction Current state of play under TD1 Changes under TD2 Some tricky issues experienced under TD1 (and how TD2 might impact them) 2

More information

Waste. Copenhagen, 3 rd September 2014. Almut Reichel Project Manager Sustainable consumption and production & waste, European Environment Agency

Waste. Copenhagen, 3 rd September 2014. Almut Reichel Project Manager Sustainable consumption and production & waste, European Environment Agency Waste Copenhagen, 3 rd September 2014 Almut Reichel Project Manager Sustainable consumption and production & waste, European Environment Agency Waste and material resources MAWP Strategic Area 1.9 Objective

More information

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT

SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT SPECIFICATIONS AND CONTROL TESTS ON THE FINISHED PRODUCT Guideline Title Specifications and Control Tests on the Finished Product Legislative basis Directive 75/318/EEC as amended Date of first adoption

More information

Differences in patterns of drug use between women and men

Differences in patterns of drug use between women and men Differences in patterns of drug use between women and men Differences in patterns of drug use between women and men Key findings Introduction Cannabis Ecstasy Tranquillisers and sedatives Alcohol and drug

More information

New environmental liabilities for EU companies

New environmental liabilities for EU companies New environmental liabilities for EU companies The ELD applies to all businesses that operate within the EU, even if the parent company is located outside of the EU. The ELD applies to all businesses,

More information

EUROPEAN YOUTH: PARTICIPATION IN DEMOCRATIC LIFE

EUROPEAN YOUTH: PARTICIPATION IN DEMOCRATIC LIFE Flash Eurobarometer EUROPEAN YOUTH: PARTICIPATION IN DEMOCRATIC LIFE REPORT Fieldwork: April 2013 Publication: May 2013 This survey has been requested by the European Commission, Directorate-General for

More information

Guidance for Industry

Guidance for Industry Guidance for Industry Food-Effect Bioavailability and Fed Bioequivalence Studies U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER)

More information

First estimate for 2014 Euro area international trade in goods surplus 194.8 bn 24.2 bn surplus for EU28

First estimate for 2014 Euro area international trade in goods surplus 194.8 bn 24.2 bn surplus for EU28 30/2015-16 February 2015 First estimate for 2014 Euro area international trade in goods surplus 194.8 bn 24.2 bn surplus for EU28 The first estimate for the euro area 1 (EA18) trade in goods balance with

More information

Equity Release Schemes in the European Union

Equity Release Schemes in the European Union Reifner Clerc-Renaud Perez-Carillo Tiffe Knobloch Equity Release Schemes in the European Union institut fur finanzdienstleistungen e.v. Contents PREFACE I EXECUTIVE SUMMARY V TABLES XXIX FIGURES XXX 1.

More information

Size and Development of the Shadow Economy of 31 European and 5 other OECD Countries from 2003 to 2015: Different Developments

Size and Development of the Shadow Economy of 31 European and 5 other OECD Countries from 2003 to 2015: Different Developments January 20, 2015 ShadEcEurope31_January2015.doc Size and Development of the Shadow Economy of 31 European and 5 other OECD Countries from 2003 to 2015: Different Developments by Friedrich Schneider *)

More information

FUSIONS Food waste data set for EU-28. New Estimates and Environmental Impact

FUSIONS Food waste data set for EU-28. New Estimates and Environmental Impact FUSIONS Food waste data set for EU-28 New Estimates and Environmental Impact 15 October 2015 Food waste is an issue of importance to global food security and good environmental governance, directly linked

More information

Customs and tax treatment of gifts received from outside Finland

Customs and tax treatment of gifts received from outside Finland www.tulli.fi Customer Bulletin nr 10 Customs and tax treatment of gifts received from outside Finland July 2015 replaces bulletin January 2013 Customs and tax treatment of gifts received from outside Finland

More information

Panel: How broadband policy can contribute to deploy secured and universal broadband access. Presentation:

Panel: How broadband policy can contribute to deploy secured and universal broadband access. Presentation: Panel: How broadband policy can contribute to deploy secured and universal broadband access Presentation: Initiatives to deploy broadband access in Europe Erik BOHLIN Chalmers University of Technology,

More information

Definition of Public Interest Entities (PIEs) in Europe

Definition of Public Interest Entities (PIEs) in Europe Definition of Public Interest Entities (PIEs) in Europe FEE Survey October 2014 This document has been prepared by FEE to the best of its knowledge and ability to ensure that it is accurate and complete.

More information

168/2014-4 November 2014. At risk of poverty or social exclusion 2 rate in the EU28, 2008-2013 (% of total population)

168/2014-4 November 2014. At risk of poverty or social exclusion 2 rate in the EU28, 2008-2013 (% of total population) 168/2014-4 November 2014 At risk of poverty or social exclusion in the EU28 More than 120 million persons at risk of poverty or social exclusion in 2013 Almost 1 out of every 4 persons in the EU in this

More information

Drink driving in Europe

Drink driving in Europe Athens 25 th of November 2009 Drink driving in Europe Antonio Avenoso Introduction to ETSC A science-based approach to road safety policy Bringing together 42 organisations from across Europe to promote

More information

TPI: Traffic Psychology International on a common European curriculum for postgraduate education in traffic psychology

TPI: Traffic Psychology International on a common European curriculum for postgraduate education in traffic psychology TPI: Traffic Psychology International on a common European curriculum for postgraduate education in traffic psychology Sucha, M.*, Sramkova, L.** DeVol, D.* * TPI - Traffic Psychology International **

More information

Clinical Study Synopsis

Clinical Study Synopsis Clinical Study Synopsis This Clinical Study Synopsis is provided for patients and healthcare professionals to increase the transparency of Bayer's clinical research. This document is not intended to replace

More information

ERASMUS+ MASTER LOANS

ERASMUS+ MASTER LOANS ERASMUS+ MASTER LOANS Erasmus+ Master Loan: opening up access to more affordable lending for cross-border studies The Erasmus+ programme makes it possible for students who want to take a full Master's-level

More information

Keeping European Consumers safe Rapid Alert System for dangerous non-food products 2014

Keeping European Consumers safe Rapid Alert System for dangerous non-food products 2014 Keeping European Consumers safe Rapid Alert System for dangerous non-food products 2014 COMPLETE STATISTICS Justice and Consumers Directorate-General for Justice and Consumers Directorate Consumers Unit

More information

I have asked for asylum in the EU which country will handle my claim?

I have asked for asylum in the EU which country will handle my claim? EN I have asked for asylum in the EU which country will handle my claim? A Information about the Dublin Regulation for applicants for international protection pursuant to article 4 of Regulation (EU) No

More information

72/2015-21 April 2015

72/2015-21 April 2015 72/2015-21 April 2015 Provision of deficit and debt data for 2014 - first notification Euro area and EU28 government deficit at 2.4% and 2.9% of GDP respectively Government debt at 91.9% and 86.8% In 2014,

More information

European Research Council

European Research Council ERC Starting Grant Outcome: Indicative statistics Reproduction is authorised provided the source ERC is acknowledged ERCEA/JH. ERC Starting Grant: call Submitted and selected proposals by domain Submitted

More information

Visa Information 2012

Visa Information 2012 Visa Information This document is intended to provide you with information on obtaining the correct visa to enter Australia to attend the Global Eco Asia-Pacific Tourism Conference however it is a guideline

More information

Questions & answers on signal management

Questions & answers on signal management 23 October 2015 EMA/261758/2013 Inspections and Human Medicines Pharmacovigilance Division This document addresses a number of questions which stakeholders, in particular marketing authorisation holders

More information

Students: undergraduate and graduate students who are currently enrolled in universities

Students: undergraduate and graduate students who are currently enrolled in universities DUO-Korea: 1. General Description CAUTION: If any application falls under the following 3 cases, the application is disqualified and will not be considered for selection. If such case is found after the

More information

ENTERING THE EU BORDERS & VISAS THE SCHENGEN AREA OF FREE MOVEMENT. EU Schengen States. Non-Schengen EU States. Non-EU Schengen States.

ENTERING THE EU BORDERS & VISAS THE SCHENGEN AREA OF FREE MOVEMENT. EU Schengen States. Non-Schengen EU States. Non-EU Schengen States. ENTERING THE EU BORDERS & VISAS THE SCHENGEN AREA OF FREE MOVEMENT An area without internal borders where EU citizens and non-eu nationals may move freely EU Schengen States Non-Schengen EU States IS Azores

More information

for people coming to Scotland to work

for people coming to Scotland to work for people coming to Scotland to work In Scotland, most health care is provided by the National Health Service (NHS). If you are coming from overseas to work in Scotland, and you live here legally, this

More information

PREPARATORY ACTION IN THE FIELD OF SPORT. Administrative and Financial Management Handbook

PREPARATORY ACTION IN THE FIELD OF SPORT. Administrative and Financial Management Handbook PREPARATORY ACTION IN THE FIELD OF SPORT Administrative and Financial Management Handbook The rules outlined in this Administrative and Financial Handbook apply to the projects funded by the Preparatory

More information

PHONE SELLING ADDITIONAL INFORMATION

PHONE SELLING ADDITIONAL INFORMATION COUNTRY PHONE SELLING ADDITIONAL INFORMATION ALLOWED Belgium The use of automatic system of phone call with a marketing goal without human intervention is not allowed without the authorization of the consumer.

More information

4. We understand this to mean that each provider state will need to ensure indemnity arrangements are in place to cover healthcare provided in that

4. We understand this to mean that each provider state will need to ensure indemnity arrangements are in place to cover healthcare provided in that Medical Defence Union response to consultation on European Commission s proposals for Directive on the application of patients rights in cross-border healthcare Introduction 1. The Medical Defence Union

More information

Annual report 2009: the state of the drugs problem in Europe

Annual report 2009: the state of the drugs problem in Europe Annual report 2009: the state of the drugs problem in Europe International Conference: New trends in drug use: facts and solutions, Parliament of the Republic of Vilnius - 5 November 2009 Dagmar Hedrich

More information

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP)

COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY MEDICINAL PRODUCTS (CVMP) European Medicines Agency Veterinary Medicines and Inspections London, 15 April 2005 EMEA/CVMP/134/02 Rev 1 CPMP/QWP/227/02 Rev 1 COMMITTEE FOR PROPRIETARY MEDICINAL PRODUCTS (CPMP) COMMITTEE FOR VETERINARY

More information

EUROPE 2020 TARGET: TERTIARY EDUCATION ATTAINMENT

EUROPE 2020 TARGET: TERTIARY EDUCATION ATTAINMENT EUROPE 2020 TARGET: TERTIARY EDUCATION ATTAINMENT Low tertiary or equivalent education attainment levels create skills bottlenecks in knowledgeintensive economic sectors and hamper productivity, innovation

More information

THE ROLE OF PUBLIC SUPPORT IN THE COMMERCIALISATION OF INNOVATIONS

THE ROLE OF PUBLIC SUPPORT IN THE COMMERCIALISATION OF INNOVATIONS Flash Eurobarometer THE ROLE OF PUBLIC SUPPORT IN THE COMMERCIALISATION OF INNOVATIONS REPORT Fieldwork: January February 2014 Publication: May 2014 This survey has been requested by the European Commission,

More information

Pre-Commercial Procurement (PCP)

Pre-Commercial Procurement (PCP) Pre-Commercial Procurement (PCP) Tsanidis Vassilis DG CONNECT F2 unit ( Innovation ) Rationale Health care Climate Change Energy Efficiency Transport Security q Public sector is faced with important societal

More information

Somulose, 400 mg/25 mg/ml, Avlivningsvätska för djur Secobarbital Sodium. Applicant: Dechra Limited

Somulose, 400 mg/25 mg/ml, Avlivningsvätska för djur Secobarbital Sodium. Applicant: Dechra Limited NATIONAL PROCEDURE PUBLICLY AVAILABLE ASSESSMENT REPORT FOR A VETERINARY MEDICINAL PRODUCT Somulose, 400 mg/25 mg/ml, Avlivningsvätska för djur Secobarbital Sodium Applicant: Dechra Limited Postadress/Postal

More information

(Only available if you have applied for a Decreasing Mortgage Cover Plan or a Level Protection Plan).

(Only available if you have applied for a Decreasing Mortgage Cover Plan or a Level Protection Plan). Mortgage protection Free cover (Only available if you have applied for a Decreasing Mortgage Cover Plan or a Level Protection Plan). At Zurich, we understand the importance of financial protection when

More information

Guide to The Notification System for Exempt Medicinal Products

Guide to The Notification System for Exempt Medicinal Products Guide to The Notification System for Exempt Medicinal Products AUT-G0090-1 10 JULY 2014 This guide does not purport to be an interpretation of law and/or regulations and is for guidance purposes only.

More information

Drink Driving in Europe

Drink Driving in Europe Safe & Sober: Reducing deaths and injuries from drink driving Copenhagen, 27 January 2010 Drink Driving in Europe Vojtech EKSLER Policy analyst Introduction to ETSC A science-based approach to road safety

More information

Chase Online SM Wire Transfer Help Guide page 1 of 16. How to Send Wire Transfers on Chase Online SM

Chase Online SM Wire Transfer Help Guide page 1 of 16. How to Send Wire Transfers on Chase Online SM Chase Online SM Wire Transfer Help Guide page 1 of 16 How to Send Wire Transfers on Chase Online SM For a convenient, secure and quick way to send money directly to someone s bank account, use a wire transfer

More information

Special Eurobarometer 423 CYBER SECURITY REPORT

Special Eurobarometer 423 CYBER SECURITY REPORT Special Eurobarometer 423 CYBER SECURITY REPORT Fieldwork: October 2014 Publication: February 2015 This survey has been requested by the European Commission, Directorate-General for Home Affairs and co-ordinated

More information

Electricity and natural gas price statistics 1

Electricity and natural gas price statistics 1 Electricity and natural gas price statistics 1 Source: Statistics Explained (http://epp.eurostat.ec.europa.eu/statistics_explained/) - 21/11/2011-09:11:44 Electricity and natural gas price statistics Data

More information

EBE Position paper on labelling of biosimilars Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)- draft April 2013

EBE Position paper on labelling of biosimilars Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)- draft April 2013 FINAL EBE 21 August 2013 EBE Position paper on labelling of biosimilars Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL)- draft April 2013 Introduction This document seeks

More information

Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE

Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Comparative analysis between the possible regulatory approaches to GMP compliance TITOLO PRESENTAZIONE Dr. Fulvio CARLOTTI, GNOSIS SpA, Corporate QA Director September 26, 2014 Scope of GMP GMP compliance

More information

Dublin, March 2013. EPSO Network of Experts in the field of Personnel Selection 14th March 2013

Dublin, March 2013. EPSO Network of Experts in the field of Personnel Selection 14th March 2013 Dublin, March 2013 EPSO Network of Experts in the field of Personnel Selection 14th March 2013 On-going and upcoming competitions AD2012 by Citizenship AD2012 Citizenship %EU Population validated application

More information

Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials

Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials Regulations for Handling Samples and Laboratory Testing from R&D through Phase III Clinical Trials Ron Hinkel, Director Quality Systems BioReliance Inc. Patti Rossman, President Globiox Purpose Keep pace

More information

HEWLETT-PACKARD COMPANY 2011 EMPLOYEE STOCK PURCHASE PLAN ( ESPP )

HEWLETT-PACKARD COMPANY 2011 EMPLOYEE STOCK PURCHASE PLAN ( ESPP ) This prospectus supplement (the Prospectus Supplement ) is supplemental to, forms part of, and must be read in conjunction with the prospectus published by Hewlett-Packard Company ( HP or the Company )

More information

SERVICE SOLUTIONS Our commitment is your peace of mind

SERVICE SOLUTIONS Our commitment is your peace of mind EMPOWERING YOUR BUSINESS SERVICE SOLUTIONS Our commitment is your peace of mind www.toyota-forklifts.eu SERVICE SOLUTIONS Our commitment is your peace of mind As you would expect of the world leader in

More information

Joint Research Centre (JRC) Economic Analysis of Electronic Identification (EID) of Small Ruminants in Member States

Joint Research Centre (JRC) Economic Analysis of Electronic Identification (EID) of Small Ruminants in Member States 1 Joint Research Centre (JRC) Economic Analysis of Electronic Identification (EID) of Small Ruminants in Member States IPSC - Institute for the Protection and Security of the Citizen Ispra - Italy http://ipsc.jrc.ec.europa.eu/

More information

RETAIL FINANCIAL SERVICES

RETAIL FINANCIAL SERVICES Special Eurobarometer 373 RETAIL FINANCIAL SERVICES REPORT Fieldwork: September 211 Publication: March 212 This survey has been requested by Directorate-General Internal Market and Services and co-ordinated

More information

Public Assessment Report. Scientific discussion. Rivamylan 4.6 mg /24 hours and 9.5 mg /24 hours, transdermal patches.

Public Assessment Report. Scientific discussion. Rivamylan 4.6 mg /24 hours and 9.5 mg /24 hours, transdermal patches. Public Assessment Report Scientific discussion Rivamylan 4.6 mg /24 hours and 9.5 mg /24 hours, transdermal patches (rivastigmine) NL/H/2958/001-002/DC Date: 30 March 2015 This module reflects the scientific

More information

Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP) 1 2 20 February 2012 EMA/541760/2011 3 4 Guideline on good pharmacovigilance practices (GVP) Module I Pharmacovigilance systems and their quality systems Draft finalised by the Agency in collaboration

More information

International Compliance

International Compliance YOUR FREE COPY - NEW - Additional countries outside European Union LEGAL WHITE PAPER International Compliance Legal requirements international einvoicing European Union & Selected Countries Worldwide International

More information

ERMInE Database. Presentation by Nils Flatabø SINTEF Energy Research. ERMInE Workshop 2 - Northern Europe Oslo, 1. November 2006

ERMInE Database. Presentation by Nils Flatabø SINTEF Energy Research. ERMInE Workshop 2 - Northern Europe Oslo, 1. November 2006 ERMInE Database Presentation by Nils Flatabø SINTEF Energy Research ERMInE Workshop 2 - Northern Europe Oslo, 1. November 26 Overview Content of the Ermine Database Electronic Questionnaire RTD&D Data

More information