A contract is signed with the European Medicines Agency (EMA) allowing a sampling and testing programme for centrally authorised products (CAP).
The European Directorate for the Quality of Medicines (EDQM) is created.
The European Union becomes a party to the Convention acting on behalf of its member states for non-technical decisions; a contract is signed between the Commission of the European Union and the Council of Europe's European Pharmacopoeia Secretariat to set up a European network of Official Medicines Control Laboratories (OMCLs); the Procedure for the Certification of Suitability comes into force.
A Memo of Understanding is signed with the European Committee for Standardisation (CEN) concerning medical devices.
A contract is signed between the Commission of the European Communities and the Council of Europe putting the European Pharmacopoeia Secretariat in charge of a biological standardisation programme; Directives 91/507/EEC and 92/18/EEC revise Directives 75/318/EEC and 81/852/EEC respectively allowing all medicines, notably biologicals, to be covered by EU law; the EDQM participates in the International Conference on Harmonisation (ICH).
The Pharmacopoeial Discussion Group (PDG) is set up with the United States Pharmacopoeia (USP) and the Japanese Pharmacopoeia (JP).
A Protocol to the Convention on the Elaboration of a European Pharmacopoeia is signed to prepare the way for the European Community to be become a full member.
Council Directive 81/852/EEC of 28 September 1981 makes compliance with European Pharmacopoeia Monographs mandatory when requesting marketing authorisation for medicines for veterinary use.
Council Directive 75/318/EEC of 20 May 1975 makes compliance with the European Pharmacopoeia Monographs mandatory when requesting marketing authorisation for medicines for human use.
The first laboratory is inaugurated making adoption, by the European Pharmacopoeia Commission, of the first texts on general methods for chemical, physical and physico-chemical analysis possible.
The Technical Secretariat is expanded and two vice-Chairs of the Ph. Eur. Commission are appointed.
On 17 March, the Convention on the Elaboration of a European Pharmacopoeia was adopted by the Committee of Ministers. The first meeting of the Ph. Eur. Commission was held on 28 April and was chaired by Mr Leon Robert (Luxembourg). This meeting marked the accession of Switzerland. Belgium became the first country to sign the Convention. In September, the Rules of Procedure governing the Ph. Eur. Commission were adopted and Mr Herbert Grainger was nominated Head of the Technical Secretariat.
On 17 November, the Council of Europe’s Public Health Committee adopted the draft Convention on the establishment of legal, administrative and technical bodies of a European Pharmacopoeia.