EU RA - An Historic Perpective

Question 1

Directive 2001/83/EC

Answer 1

6 Nov 2001 - of the EU Parliament and of the Council. On the Community code relating to medicinal products for human use.

Question 2

Council Directive 89/432/EEC

Answer 2

12 June 1989 - First EU biologic product directive. on the introduction of measures to encourage improvements in the safety and health of workers at work.

Question 3

Regulation 1394/2007/EC or the EU Parliament and of the Council

Answer 3

13 Nov 2007 - On advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 724/2004.

Question 4

Council Directive 81/851/EEC

Answer 4

28 Sept 1981 - First EU veterinary product directive. On the approximation of the laws of the Member States relating to veterinary medicinal products.

Question 5

Council Directive 93/42/EEC

Answer 5

14 June 1993 - Concerning medical devices.

Question 6

Council Directive 2007/47/EC of the EU Parliament and of the Council

Answer 6

5 Sept 2007- Amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, the Council Directive 93/42/EEC concerning medical device and Directive 98/8/EC concerning the placing of biocidal products on the market.

Question 7

Council Directive 65/65/EEC

Answer 7

26 Jan 1965 - First EU Medicinal product directive. on the approximation of provision laid down by law, regulation or administrative action relating to medicinal products.