Importing
Medicinal products holding marketing authorisations within the EU
Importation from another EU member state is considered to be ‘wholesale distribution’, for which a Wholesale dealer’s licence is required. (Medicines Act Section 8 [external link] and The Medicines for Human Use [Manufacturing, Wholesale Dealing and Miscellaneous Amendments] Regulations 2005 No. 2789 [external link]).
A medicinal product may be imported into the UK in accordance with the rules of theEuropean Commission relating to parallel Iiports. In such cases, a marketing authorisation must be held in the UK before such a product can be placed on the market – a parallel import licence (see section below).
Imports from non EU/European Economic Area (EEA) countries
Medicinal products from outside the EU must conform to good manufacturing practices at least equivalent to EU standards.
The importer must hold a manufacturer’s licence covering importation (Medicines Act Section 8 [external link] and The Medicines for Human Use [Manufacturing, Wholesale Dealing and Miscellaneous Amendments] Regulations 2005 No. 2789 [external link]).
Parallel importing
Parallel importing (also known as parallel distribution) occurs when a product placed on the market in one country is bought by an intermediary who exports it to another country, without permission of the marketing authorisation holder. Parallel importing is permitted between EU member states and occurs where products are priced differently in each country.
Parallel imports must be manufactured to GMP standards, the importer must hold a wholesale dealer’s licence covering importation, storage and release and a manufacturer’s licence covering assembly to enable the re-packaging and re-labelling of products.
The requirements relating to parallel imports are described in the Commission Communication on Parallel Imports: COM(2003) 839 Final (external link).
To ensure that the imported product complies with UK national regulations, companies wishing to import medicinal products on this basis must apply for a licence for each individual product and the importer must hold the relevant Wholesale Dealers' licence. The MHRA operates a simplified procedure to approve authorisations for parallel importation.
Unlicensed medicinal products
Import of unlicensed medicines may be necessary if there is no UK licensed equivalent suitable for an individual patient.
The importer must hold a Wholesale Dealer’s Licence which specifies that it covers unlicensed relevant medicinal products. (Links to Guidance note 6
(279Kb) and 14.).
The relevant legislation is The Medicines for Human Use (Manufacturing, Wholesale Dealing and Miscellaneous Amendments) Regulations 2005 No. 2789 (external link). The European legal basis for this is Article 5 of Directive 2001/83/EC (exernal link).
Exports
Exporting to another EU member state is considered to be wholesale distribution as described in the importing section above. If any assembly activity is required, then a Manufacturer’s Licence would be required as well. Guidance is available to exporters.
Trading Medicines for Human Use: Shortages and Supply Chain Obligations (32Kb)
To export to countries outside the EU, the destination country will usually require evidence of the marketing authorisation and/or manufacturing status in the country of origin.
The MHRA can provide the following types of export certificate:
- Certificate of a Pharmaceutical Product - which conforms to the WHO Export Certificate
- Certificate of Manufacturing Status
- Certificate of Licensing Status
- Certificate of Pharmaceutical Constituent.
Further details and forms are available in the Exporting medicines section of ther website.
Investigational medicinal products
The manufacture and/or importation of investigational medicinal products requires a manufacturing licence (MIA[IMP]). The licence is also required if products manufactured in the UK are to be exported to third countries for use in clinical trials.
Manufacturers and Wholesale Dealers licences
