The UK Parallel Import Licensing Scheme allows medicinal products authorised in other EU Member States to be marketed in the UK, provided the imported products have no therapeutic difference from the equivalent UK products.
The granting of licences in the EU for such a purpose began in 1984. The MHRA liaises closely with the relevant competent authorities to get the necessary information to ensure that only those products which fully comply with the stringent criteria for parallel import are granted a licence.
Parallel import licence application categories
From 1 April 2009 Parallel Import Licence applications are in one of three categories. The fees for the categories are different so it is important that the correct category is selected. The categories are:
Parallel import (simple)
This category will apply when the UK product and the product to be imported from a Member State are manufactured by companies in the same group of companies or are made under licence from the same licensor. This is the traditional ‘common origin’ criterion.
Parallel import (standard)
This category will apply when the UK and imported products do not share a common origin (as defined above) and the application is not ‘Complex’ (see below).
Parallel import (complex)
This category will apply when the UK and imported products do not share a common origin (as defined above) and:
- (a) the imported product contains a new excipien
- (b) the imported product contains an active ingredient made by a different route from that used in the UK product
- (c) the imported product is a controlled release preparation
- (d) the imported product is a sterile product which is sterilised in a different way from the UK product
- (e) the imported product is a sterile product in which the container is made from a different material to the container of the UK product
- (f) the imported product is an influenza vaccine
- (g) the product is a metered dose inhaler
- (h) the product is a powder for inhalation
- (i) bioequivalence of the UK and imported product cannot be demonstrated through bioavailability studies
- (j) the sole or primary evidence for the safety and efficacy of the imported product consists of published scientific literature
- (k) the manufacturer of the active ingredient contained in the imported product is different from the manufacturer of the active ingredient contained in the UK product.
For the standard and complex categories, companies will be required to submit suitable pharmacovigilence plans (see separate guidance) with the application.
Application forms
Application for a product licence (parallel importing) 
(54Kb)
Application for variation of a product licence (parallel importing) (41Kb)
Application to renew a product licence (parallel importing) (31Kb)
Guidance
Guidance note for PLPI companies on user testing of patient information leaflets - updated February 2009
(268Kb)
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)
Conditions for patient consultation by similarity to the UK leaflet - March 2009 (40Kb)
This guidance is supplementary to guidance on user testing of patient information leaflets in the Labels, patient information leaflets and packaging for medicines section.
Fees
| Parallel import licence applications | Fees |
|---|---|
| Complex application | 19,650 |
| Standard application | 7,201 |
| Simple application | 1,937 |
Pharmacovigilance requirements
There are a small number of instances where a parallel importing company is required to take on responsibility for pharmacovigilance. Examples of such instances include: when the UK reference product licence has been cancelled, when there is no common origin between the UK and imported products (Standard and Complex parallel import applications).
The pharmacovigilance requirements which must be satisfied are described in the document available below. Essentially these are the same as the requirements placed on marketing authorisation (MA) holders.
Pharmacovigilance for parallel imports products (57Kb)
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)
Application to leaflet variations - July 2009 (34Kb)
Contact for further information
For further information, please contact our Parallel Import Section, MHRA, 151 Buckingham Palace Road, London SW1W 9SZ, telephone 020 3080 7400 or email info@mhra.gsi.gov.uk.
