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European Commission
Direcorate-General for Health and Food Safety

Health systems and products
Medical products - quality, safety and innovation

This document sets out frequently-asked 'questions and answers' regarding the implementation of the rules on the safety of medicinal products for human use.

These rules are enshrined in Articles 47a, 54 (o) and 54a of 2001 / 83 / EC Directive, and in the Commission Delegated Regulation (EU) No 2016 / 161.

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The A3P Association is a major player in the pharmaceutical and biotechnology industry.
Created in 1986, it contributes to the good development of the production of medicines and clean and sterile equipment, it runs a network of professionals 21 000, manufacturers and suppliers, as part of International Congress and technical days.

It now has over 1700 members who share their technical experience, scientific and regulatory.

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