EU legislation and regulation documents

Better regulation of veterinary pharmaceuticals report

50 years EU Pharma

EU pharma milestones - European Commission

Council Directive 65/65/EEC on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products

General basis for market authorisation of medicinal products

Second Council Directive on the approximation of provisions laid down by Law, Regulation or Administrative Action relating to proprietary medicinal products

Expands general basis of Directive 65/65/EEC (The manufacture, control, supervision, import and export rules were later on also binding for homeopathic and anthroposophic medicinal products later Directive 92/73/EEC refers to 75/319/EEC)

75/318/EEC

75/318/EEC

81/851/EEC

Regulation n°2377/90

92/73/EEC

92/74/EEC

2001/82/EC

2001/83/EC

2004/27/EC

2004/24/EC

2004/28/EC

Regulation n° 1901/2006

2001/83/EC

2009/53/EC

2010/84/EU

2012/26/EU

2011/62/EU

Study on the Availability of Medicinal Products for Human Use

Study on the Availability of Medicinal Products for Human Use, Matrix Insight report

Communication from the Commission to the Council and the European Parliament

Report on the experience acquired as a result of the application of the provisions of Chapter 2a of Directive 2001/83/EC (introduced by Directive 2004/24/EC) on specific provisions applicable to traditional herbal medicinal products - Document on the basis of article 16i of Directive 2001/83/EC

Report on EMEA Workshop on Homeopathic Medicinal Products

Part of the conclusion states: “The level of participation was high and it was greatly appreciated that representatives from users, patients, healthcare professionals, industry and regulators were willing to attend the workshop and have a frank exchange of views concerning current challenges and potential solutions. This report will be transmitted to the European Commission for consideration of the next steps in the area of homeopathic medicinal products.”

Common Position (EC) No 61/2003

The Council once more rejected the proposal of a compulsory version of ‘Territory specific rules’ for pre-clinical tests and clinical trials for homeopathic medicinal products not eligible for a special simplified registration in second reading. An extension of the routes of administration under the special simplified registration procedure was also rejected. The proposed amendment introducing a mutual recognition procedure for registered homeopathic medicinal products was only accepted after a compromise proposal (the Council took a negative stance towards a MR for HMP’s during earlier stages of the codecision, but found both Parliament and Commission on its way).