EU Pharmaceutical informations
Pharmaceuticals Archives - 2001
Publication of EU Pharmacovigilance Rules : Volume 9 of The Rules Governing Medicinal Products in the European Union
In accordance with Article 106 of Directive 2001/83/EC and Article 77 of Directive 2001/82/EC, Volume 9 of the Rules governing Medicinal products in the European Union (Eudralex ) on Pharmacovigilance for human and veterinary medicinal products has been published by the Commission today. This Volume has been prepared in close consultation with the European Agency for the Evaluation of Medicinal Products (the Agency), member states and interested parties. It brings together, for the first time, general guidance on the requirements, procedures, roles and activities in pharmacovigilance, for both industry and regulators of medicinal products. It also incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH) and makes specific reference to the international terminology, MedDRA. Today's publication coincides with the date on which Member States have to comply with Directives 2000/38/EC and 2000/39/EC which amended the pharmacovigilance chapters of Directives 75/319/EEC and 81/851/EEC respectively. These amendments are now integrated into the two codifying Directives on the Community Codes relating to medicinal products for veterinary and human use (2001/82/EC and 2001/83/EC ) referred to above (see also the news entry of 28/11/01).
The two codifying Directives on the Community Codes relating to medicinal products for veterinary and human use (2001/82/EC and 2001/83/EC) have been published in today's Official Journal no. L 311 of 28.11.2001. The texts are available as .pdf files
Directive 2001/82/EC (veterinary medicinal products)
Directive 2001/83/EC (human medicinal products)
Today, the European Court of Justice has issued the first judgment concerning the application by a Member State of Directive 89/105/EEC on the transparency of measures regulating the prices of medicinal products for human use and their inclusion in the scope of national health insurance systems.
Review of Pharmaceutical Legislation
Today the commission has officially transmitted to the European Parliament and the Council the three legislative proposals concerning the review of the Community Pharmaceutical Legislation
- Proposal for a Regulation of the European Parliament and of the Council laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products
- Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use
- Proposal for a Directive of the European Parliament and of the Council amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products
Revision of Good Manufacturing Practices annex 13 to implement directive on Clinical Trials on medicinal products for human use.
Following discussion within the working parties on medicinal products and inspections (Good manufacturing practices and Good clinical practices sectors) the Annex 13 "Manufacture of investigational medicinal products" of the Guide provided by the Commission Directive 91/356/EEC laying down the principles and guidelines of good manufacturing practices (GMP) for medicinal products for human use (Volume 4 - Pharmaceutical legislation - Good manufacturing practices) has been revised in order to implement the "Detailed Guidelines" for the manufacture and the labelling of investigational medicinal products as provided for in Directive 2001/20/EC relating to the implementation of good clinical practice in the conduct of clinical trails on medicinal products for human use.
The draft 1 is released for a 6 months consultation period.
COMMENTS ARE EXPECTED BEFORE 1 MAY 2002 and should be sent to firstname.lastname@example.org
Substances considered as not falling within the scope of Council Regulation (EEC) No 2377/90. Updated version (revision 2) from the Committee for Veterinary Medicinal Products.
The Committee for Veterinary Medicinal Products (CVMP) having reviewed all applications for the establishment of MRLs for "old substances" to be considered under Council Regulation (EEC) No 2377/90, considered that some substances were normal components of human food, biologically inert when orally taken, or not classified as chemicals. An up-to-date list of substances that are considered by the CVMP as not being within the scope of Council Regulation 2377/90 is now available.
Notice to applicants, Volume 2B, Common Technical Document (CTD) QUESTIONS AND ANSWERS
In order to help the implementation of the CTD in the EU form on administrative perspective, a document called "QUESTIONS AND ANSWERS" has been prepared. It concerns only regulatory or administrative questions. The first question concerns how to prepare the CTD where there are "mixed" dossiers with some parts in the "old" format (parts I, II ,III and IV) and some others in the new CTD format (modules 1, 2, 3, 4 and 5). This document will be regularly completed with new questions and answers.
A new Volume 6C - Regulatory Guidelines has been created in the Notice to Applicants Veterinary Medicinal Products with the aim to have all guidelines on regulatory matters under an easily identifiable heading. The Notes for Guidance and other documents included in this volume are not new and have been transferred from Volumes 6A, 6B and 2C. This volume mimicks volume 2C already created for medicinal products for human use.
Report on the operation of the authorisation procedures for medicinal products adopted and available in all languages of the European Community
Today, the Commission adopted the report on the experience acquired as a result of the operation of the procedures for granting marketing authorisations for medicinal products laid down in Regulation (EEC) N° 2309/93, in chapter III of directive 75/319/EEC and chapter IV of directive 81/851/EEC. This report is based on Article 71 of Regulation (EEC) No 2309/93
Position paper on the use of starting materials of ruminant origin in veterinary medicinal products intended for use in ruminant species (EMEA/CVMP/121/01 February 2001) available in all languages of the European Community
This position paper on the use of starting materials of ruminant origin in veterinary medicinal products for use in ruminant species should be seen and used in conjunction with joint CPMP/CVMP Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy (TSE) agents via human and veterinary medicinal products.
Position paper on the assessment of the risk of transmission of animal spongiform encephalopathy agents by master seed materials used in the production of veterinary vaccines (EMEA/CVMP/019/01 February 2001) available in all languages of the European Community.
This position paper on master seed materials used in the production of veterinary vaccines should be seen and used in conjunction with joint CPMP/CVMP Note for Guidance on minimising the risk of transmitting animal spongiform encephalopathy (TSE) agents via human and veterinary medicinal products.
Updated Note for guidance on minimising the risk of transmitting animal spongiform encephalopathy agents via human and veterinary medicinal products (EMEA/410/01 Rev.1 May 2001) available in all languages of the European Community
This joint CPMP/CVMP Note for Guidance is a revised version of the respective CPMP and CVMP Notes for Guidance on minimising the risk of transmitting TSE via medicinal products. Compliance with this Note for guidance has to be demonstrated according to Council Directive 75/318/EEC as amended by Commission Directive 1999/82EC) and Council Directive 81/852/EEC as amended by Commission Directive 1999/104/EC
New version of compilation of Community procedures on inspections and exchange of information
An updated compilation of administrative procedures for GMP inspections has been prepared.
This compilation updates and replaces document III/5698/94 which had been prepared within the ad hoc group of inspectors and published by the Commission. It includes guidance for inspectors on rapid alerts, exchange of information between inspectorates, batch certificates and a format for a community inspection report.
Updated version of Chapter 3 "Community referral" in volume 6A Notice to Applicants October 2001
DG Enterprises releases a revised version of Chapter 3 "Community referral" prepared by the Notice to Applicants Working Party. The chapter describes the procedures in general and should provide useful guidance to applicants and marketing authorisation holders for veterinary medicinal products. The chapter is based on the procedures and guidance provided for in volume 2A for human medicinal products, as the experience with Community referrals in the area of veterinary medicinal products to date is limited.
This chapter is part of the "Notice to applicants" "Veterinary Medicinal Products" Volume 6A of "The rules governing medicinal products in the European Union".
Notice to applicants, Volume 2B, Common Technical Document (CTD)
A Word version is available to enable the downloading of tables from Module 2.6 Non Clinical Summary and Module 2.7 Clinical Summary.
The tables concerned are:
- for Module 2.6 Non Clinical Summary: from 22.214.171.124 to 126.96.36.199
- for Module 2.7 Clinical Summary: from 188.8.131.52 to 184.108.40.206
ICH guideline published as annex to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4On 18th July 2001, the Commission adopted a new legislative proposal which introduces a requirement for pharmaceutical manufacturers to use only active substances which have been manufactured according to GMP in the manufacture of medicinal products. Until this comes into force requirements for GMP for active substances and hence the applicability of this guideline will not be mandatory in the EU. However when there are causes for concern, or when required by certain Member States, GMP inspections of active ingredient manufacturers may be carried out by the competent authorities of Member States. In these cases, and in particular when these are performed in the context of an application for a centralised authorisation, it has been agreed that the inspectors of the competent authorities in the EU will inspect against the requirements in this guideline, now published as Annex 18 to the EU guide to Good Manufacturing Practice.
EudraLex Volume 4
New annexes to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4
Following discussion within the Working party on medicines and inspections, 4 new annexes to Eudralex Volume 4 of the Rules governing medicinal products in the Community have been finalised. Annex 6 is a revision to the current annex on Manufacture of Medicinal gases and should replace current requirements from September 2001. Annex 15 on Qualification and Validation is also due to come into operation In September 2001. Annex 16 concerns the arrangements for Certification by a Qualified Person and Batch Release in the Community and is due to come into operation from January 2002. Annex 17 addresses Parametric Release and is also due to come into operation in January 2002. These annexes will also be translated into the current language versions of Eudralex Volume 4.
EudraLex Volume 4
Operational phase of the EU-Australia MRA to begin on 1st July 2001 for Veterinary Medicinal Product
Following the successful completion of the transitional arrangements for veterinary medicinal products foreseen in part IV the Mutual Recognition Agreement (MRA) between EU and Australia, the operational phase will begin for veterinary medicinal products on July 1st 2001. This extends the already successful recognition of the results of GMP inspections carried out in the respective territories for medicinal products for human use to cover also the recognition of inspections of veterinary medicinal products. Procedures to facilitate the operation of the agreement affecting both types of products were also agreed. These include agreement on a system for exchange of information on product defects (rapid alert), and standard formats for certificates of GMP compliance and batch certificates. A copy of the report prepared for the joint committee set up by this agreement is provided.
Corrigendum to Guideline 3A-Q4A of Volume 3A of The Rules Governing Medicinal Products in the European Union
It has come to our attention that page 27 of Volume 3A of The Rules Governing Medicinal Products in the European Union contains a typographical error. In section 4.2, paragraph C of The use of Ionising radiation in the manufacture of medicinal products, >107cfu/single unit should read . We apologise for any inconvenience caused by this mistake.
Revision of Annex 1 to Volume 4 of The Rules Governing Medicinal Products in the European Union
Following discussion in the EU inspectors' group, Paragraph 42 of Annex 1 to Volume 4 of The Rules Governing Medicinal Products in the European Union has been revised to take account of current practices. These changes have necessitated three additional entries in the glossary. The changes have been introduced in English into the relevant part of the documents on this web-site. Translations of the changes will be available in the near future and the corresponding edits will be made. The changes are indicated here for your information
(EudraLex Vol 4)
Press release from ICH Steering Committee and Expert Working Group meetings, Tokyo, 19th - 24th May 2001
DG Enterprise publishes its first inventory of national and community measures supporting research into and availability of orphan medicinal products
The Regulation on Orphan Medicinal Products adopted last year requires Member States to communicate to the Commission detailed information concerning any measure that have enacted to support research into, and the development and availability of, orphan medicinal products or medicinal products that may be designated as such. On the basis of this information, the Commission has prepared a first detailed inventory of all incentives made available by the Community and the Member States to support research into and availability of orphan medicinal products, thus meeting its obligations according to the regulation. This inventory shall be updated regularly.