News and updates on pharmaceuticals
Pharmaceuticals Archives - Up to 2000
Guideline on Packaging information of veterinary medicinal products authorised by the Community
The Veterinary Pharmaceutical Committee adopted the revised guideline during its last meeting held on 18/19 October 1999.
A document describing the conduct of pharmacovigilance for products authorised using the mutual recognition procedure has been agreed . This text will become part of Volume IX of The rules governing medicinal products in the European Union.
The thirteenth meeting of the Transparency Committee, established under Directive 89/105/EEC (and often referred to as "the Transparency Directive"), took place in Brussels on 30th March 1999. The Committee, which is made up of Member State representatives responsible for the pricing and reimbursement of pharmaceuticals, advises the Commission on matters relating to the Transparency Directive. A summary note of the meeting is available.
Summarised new edition of the Annexes I to IV of Council Regulation 2377/90 published!
The results of the residue evaluations according to Council Regulations 2377/90 (e.g. maximum residue limits = MRLs) adopted by the Commission by 1 January 1999 have been summarised and published as Commission Regulation (EC) No 508/1999 of 4 March 1999 amending Annexes I to IV of Council Regulation (EEC) No 2377/90 laying down a Community procedure for the establishment of maximum residue limits of veterinary medicinal products in foodstuffs of animal origin in the Official Journal L 060, of 9 March 1999 on pages 16 - 52. (see MRL section)
Inspection and Control of medicinal products - information on the outcome of the expert group meeting on 17 and 18 December 1998.
DGIII launches consultation on Electronic Commerce: Following a first discussion in the Paris Round Table on completing the Single Market in Pharmaceuticals, the Commission has launched a consultation on the report on E-commerce in the pharmaceuticals sector prepared by Ashurts, Morris and Crisp. Comments have been invited by 26th February 1999.
Information on the outcome of the 1st meeting of the group "Pharmacovigilance Policy: Medicines for Human and veterinary Use, 20th November 1998 (see Documents section)
Launch of new simplified procedure for recognition of centralised authorisations by Competent authorities in Central and Eastern Europe
Following consultation and agreement between CADREAC countries, a common simplified procedure for granting of marketing authorisations for centrally authorised medicinal products for human use came into operation on 1st January 1999. This procedure is optional and at the request of the Marketing Authorisation holder in the EU. The acceptance of this procedure by the countries concerned represents a significant step in the preparation of CEEC countries for accession to the EU, at the same time ensuring best use of limited resources. Further information is available on the EMEA web-site
The fourth TransAtlantic Business Dialogue (TABD) Conference took place on 5-7 November in Charlotte, North Carolina. Sectoral discussions were held on both Pharmaceuticals and Cosmetics . The "Charlotte Statement of Conclusions" can be found at http://www.tabd.com
A revised guideline on Control Authority Batch Release of Vaccines and Blood Products.
In September 1998 the Pharmaceutical Committee approved a revised guideline on Control Authority Batch Release of Vaccines and Blood Products which will replace two 1994 guidelines, one for vaccines and the other for blood products (III/3859/92). It has been drafted by the Network of EU OMCLs responsible for official batch release of vaccines and blood products in consultation with the industry. It will facilitate and improve the transparency of the mutual recognition of official batch release. Annex IId: the Control authority batch release certificate of approval for plasma pools, will be include once it has been finalised (later this year).
The Commission has adopted two Decisions concerning medicinal products for human use which contain terfenadine, pursuant to Article 12 of Directive 75/319/EEC. On the one hand, Member States concerned are requested to withdraw national marketing authorisations for tablets containing either 120 mg terfenadine or 60 mg terfenadine + 120 mg pseudoephedrine hydrochloride. On the other hand, Member States concerned are requested to maintain the marketing authorisations for tablets containing either 30 mg or 60 mg terfenadine and for oral suspensions containing 6 mg/ml terfenadine; the summary of the products characteristics of these approducts however have to be adapted in accordance with the EMEA opinion.
Speaking at the annual conference of the European Federation of Pharmaceutical Industry Associations in Berlin , Commissioner Bangemann addressed two themes. On biotechnology, the Commissioner outlined a range of recent developments (particularly biotech patenting) and stressed the importance of gaining and developing public confidence in these new sector. On the Single Market in Pharmaceuticals, the Commissioner underlined the need for a more thorough examination of how greater reliance on market forces, including liberalisation and competition, might help address the challenges of market regulation in the pharmaceutical sector.
Inspection and GMP . Information on the outcome of the Expert Group on Inspection and Control of medicinal products Meeting 20 March 1998
GMP for medicinal products derived from human blood or plasma . DG III releases a draft revision of Annex 14 to the EU Guide to Good Manufacturing Practice, comments are requested before 31 August 1998
Addressing the AESGP 34th Annual Meeting in Athens, Commissioner Bangemann has taken stock of progress towards a Single Pharmaceutical Market, following the two Frankfurt Round Tables and the recent discussions at the Internal Market Council. The emphasis of the meeting was on the economic and social contribution of responsible self-medication to an efficient healthcare system. In this context, the Commissioner underlined the importance of improving conditions - including price deregulation - for the European OTC market.
The Agreement on Mutual Recognition between the European Community and the United States of America has been signed by Margaret Beckett (United Kingdom Secretary of State for Trade and Industry) and Commissioner Sir Leon Brittan for the Community and by Charlène Barshefsky (United States Trade Representative). It consists of a framework agreement and sectoral annexes on Telecommunication Equipment, Electromagnetic Compatibility (EMC), Electrical Safety, Recreational Craft, Pharmaceutical Good Manufacturing Practices (GMPs), and Medical Devices. The agreement shall enter into force on the first day of the second month following the date on which the letters confirming the completion of their respective procedures for the entry into force have been exchanged. For the pharmaceutical sector this means that the three year transition period will probably start on 1 August 1998.
The European Parliament has endorsed the Council's common position on the legal protection of biotechnological inventions in its 2nd reading. The Directive will be finally adopted by the Council at one of its next meetings.
Representatives of the United States Food and Drug Administration (FDA), the European Commission DG III and the European Agency for the Evaluation of Medicinal Products (EMEA) met in London on 1-2 April 1998 to exchange initial views on the implementation of the Sectoral Annex for Pharmaceutical Good Manufacturing Practice of the US-EC Mutual Recognition Agreement. The scope of the meeting was to develop a better understanding of each others regulatory system and the responsibilities of the organisations to be involved in the implementation of the Sectoral Annex. The discussions included GMP inspections and mechanisms for the exchange of information. The participants agreed to maintain informal contacts until the Agreement becomes effective and to exchange information in preparation for the first meeting of the Joint Sectoral Committee, which is anticipated to take place in the United States in September 1998.
Meeting between the European Commission, the EMEA and the Drug Regulatory Authorities of Central and Eastern European Countries. The European Commission (DG III E 3 and TAIEX) co-organised together with the EMEA (European Agency for the Evaluation of Medicinal Products) a meeting with the Drug Authorities of CEECs (Central and Eastern European Countries) which was held in London on 25-26 November 1997. The discussion focused on collaboration and association of CEECs to the EU Registration system for medicinal products. The conclusion of a Collaboration Agreement of Drug Regulatory Authorities in EU Associated Countries was announced; the participation of up to two CEECs representatives as observers to certain EU/EMEA committees with consultative role starting in 1998 was suggested; the improvement of exchange of information between the EU and the CEEC was stressed as essential - the extension of EudraNet and EudraMat to CEECs being one of the main objectives - as well as the exchange of trainees and officials. The need for a wider Pan-European Regulatory Forum was also discussed.
DG III has released the First draft of a proposal for a European Parliament and Council Directive on GMP for starting materials and inspection of manufacturers of both medicinal products and their starting materials (amending Directives 75/319/EEC and 81/851/EEC). This draft was developed in the light of the responses received to the concept paper on a Community regulatory framework on good manufacturing practice (GMP) and certification of starting materials. Comments are requested by 15 January 1998.
Council Directive 93/41/EEC of 14 June 1993 repealing Directive 87/22/EEC on the approximation of national measures relating to the placing on the market of high- technology medicinal products, particularly those derived from biotechnology
Official Journal L 214 , 24/08/1993 P. 0040 - 0040
Council Directive 87/22/EEC of 22 December 1986 on the approximation of national measures relating to the placing on the market of high-technology medicinal products, particularly those derived from biotechnology
Official Journal L 015 , 17/01/1987 P. 0038 - 0041