Regulation 17 Manufacturing of medicinal products

manufacture a medicinal product,

assemble a medicinal product,

import a medicinal product into Great Britain from a country other than—

import a medicinal product into Northern Ireland from a country other than an EEA State, or

possess a medicinal product for the purpose of any activity in sub-paragraphs (a) to (d).

manufacture and assembly of medicinal products, except for advanced therapy medicinal products, MM medicinal products, POC medicinal products or special medicinal products;

import of medicinal products, except for special medicinal products, MM medicinal products or POC medicinal products;

manufacture and assembly of advanced therapy medicinal products;

manufacture and assembly of MM medicinal products;

manufacture and assembly of POC medicinal products;

manufacture and assembly of special medicinal products;

import of special medicinal products.

if the product has a marketing authorisation, Article 126a authorisation, certificate of registration or traditional herbal registration; and

to the extent that the manufacture or assembly of the product is in accordance with the terms and conditions of that authorisation, certificate or registration.

a marketing authorisation issued by a competent authority in accordance with the 2001 Directive; F5...

a UK marketing authorisation; or

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provides facilities solely for transporting the product; or

acting as an import agent, imports the medicinal product solely to the order of another person who holds a manufacturer's licence authorising the importation of the product.

special medicinal products, F9...

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the medicinal product has undergone—

the batch release of the medicinal product has been undertaken—

the medicinal product has a UKMA(UK) or UKMA(NI); F11and

the importation of the medicinal product is with a view to its sale or supply in Northern Ireland only; F12...

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