The following Life Sciences guidance note Produced in partnership with Peter Feldschreiber, 4 New Square, Lincolns’ Inn provides comprehensive and up to date legal information covering:
In the EU, Article 6 of Directive 2001/83/EC (consolidated version 28.01.2019), the Pharmaceutical Code establishes the general rule that no medicinal product may be placed on the EU market without first having been granted a marketing authorisation (MA) by the relevant competent authority (ie the European Commission in the case of centrally authorised medicinal products or a national competent authority in the case of decentralised, mutual recognition or purely national authorisation procedures). See Practice Note: Marketing authorisations—regulatory procedures for approval of medicinal products. In the UK, the Pharmaceutical Code is implemented by the Human Medicines Regulations 2012 (HMRs), SI 2012/1916. HMRs, reg 46 prohibits the supply or offer to sell or supply, unauthorised medicinal products, as well as the supply or offer to sell or supply medicinal products outside the terms of their MA.
However, regulatory authorities and legislators worldwide have recognised the need to accelerate access to market of new and innovative medicinal products in certain circumstances. Consequently, a number of exemptions to the requirement for a prior MA have developed which allow an unauthorised medicinal product to be supplied and distributed to patients.
These broadly fall within the following categories:
unauthorised products supplied on the basis of Article 5(1) of the Pharmaceutical Code, known as ‘named patient’
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