Parallel import licences

The granting of licences in the EU for such a purpose began in 1984. The MHRA liaises closely with the relevant competent authorities to obtain the necessary information to ensure that only those products which fully comply with the stringent criteria for parallel import are granted a licence.

Application forms
› Application for a product licence (parallel importing) (54Kb)
› Application for variation of a product licence (parallel importing) (51Kb)

Guidance
› Guidance note for PLPI companies on user testing of patient information lealfets (43Kb)
› Additional guidance on PIL user testing for PLPI products (477Kb)
› Quality criteria for patient information leaflets and good examples of user tested UK leaflets
› Questions and answers on PLPI patient information leaflet user testing (64Kb)
› Bridging applications - Update (15Kb)

This guidance is supplementary to guidance on user testing of patient information leaflets in the Labels, Patient Information Leaflets and Packaging for Medicines section.

Two strikes and out initiative
Following successful consultations with our external stakeholders, an implementation date has been agreed for the ‘two strikes and out initiative’.

From the 7 January 2008, the agency will correspond with the applicant twice, to explain the information which is missing or the changes which are required. If after this the applicant has not sent the information or made the required changes within the time specified in the correspondence the Agency will make a decision whether or not to grant the parallel import licence.

For applications where assessment commenced before the 7 January 2008, any letter sent on and/or after this date will be considered the first correspondence.

A third and final letter will be sent before the application is determined as refused.

Exemptions to this rule will be allowed in exceptional circumstances, for example when the leaflet is undergoing user testing. These exemptions will be decided on a case by case basis.

To facilitate the assessment process and to ensure that an application is processed without delay an application for a parallel import licence should be accompanied by the following particulars and documents. These documents are required so that the Agency can ascertain whether the product is one to which the parallel import scheme applies and whether it may be safely marketed in the UK:

• an accurately completed MLA form indicating the appropriate UK cross-reference product on which the application is based
• the relevant complete sample with the foreign leaflet intact
• mock ups of all proposed labelling and patient information leaflet (PIL) in English
• the appropriate fee should be paid immediately on receipt of the invoice

Additional guidance is also be available on the implementation of the initiative:
› Parallel import applications - Guidance concerning requests for further information (RFIs) (24Kb)

Contact for further information
For further information, please contact our Parallel Import Section, 11-1, MHRA, Market Towers, 1 Nine Elms Lane, London SW8 5NQ, telephone 020 7084 3528, fax 020 7084 2323 or e-mail info@mhra.gsi.gov.uk.