The statement, on letter-headed paper, should be signed and emailed as a PDF to and include this wording: You do not need to send a list of suppliers you will obtain the product from if you electronically submit the statement below. Your application must inform MHRA of which companies will be carrying out each function associated with import of a product by either putting them on the application form or attaching a list covering all the sites with their relevant manufacturer/importer or wholesale dealer licence numbers.įor all function sites outside the UK and within the EEA member states, MHRA need proof that the site holds the relevant licence from the regulatory authority in that country. See guidance on user testing information leaflets for parallel imported licences ( PDF, 276KB, 10 pages) Company functions involved in parallel importing However, if there are significant changes following user testing of the UK PIL, more testing may be necessary for the parallel import PIL to bring it in line with the UK version. PLPI companies can do their own user testing before the UK PIL has been user tested, as long as the tests show that users can find and understand the key messages in the leaflet. User testing patient information leaflets These warnings must be included even if they weren’t present on the UK packing and PIL. You should email MHRA Customer Services at if you need more information.Īll excipients in parenteral, ophthalmic and topical medicinal products must appear on the labelling.įor all other medicines, only excipients of known effect should be declared on the labelling.Įuropean Medicine Agency guidelines give the wording for the patient information leaflet and packaging for these excipients. Please see our guidance on submitting applications for labels, patient information leaflets ( PILs) and packaging for more information, although not all is relevant for parallel imports. Labels, patient information leaflets and packagingĪll labels, patient information leaflets ( PILs) and packaging for parallel import medicines must comply with current guidance. This category applies when the UK and imported products do not share a common origin (as defined above) but the application is not considered to be complex. the imported product is an influenza vaccine.the imported product is a sterile product in which the container is made from a different material to the container of the UK product.
the imported product is a sterile product which is sterilised in a different way from the UK product.the imported product is a controlled release preparation.the imported product contains an active ingredient made by a different route from the UK product.the imported product contains a new excipient.This category applies when the UK and imported products do not share a common origin (as defined above) and: This is the traditional ‘common origin’ criterion for parallel import licences. a licensing agreement exists between the market authorisation holders.the holder of the UK marketing authorisation and the holder of the marketing authorisation for the product to be imported from a Member State are held by companies in the same group or.Parallel import (simple)Ī simple parallel import licence can be granted when: PLPI applications fall into 3 categories. Parallel import licence application categories To notify MHRA you should call 020 3080 6574 or use the defective product form on the Yellow Card website. The records you keep must be suitable for this, and you must notify MHRA immediately and give the reason if you decide to withdraw a product. If a PLPI product needs to be recalled you must arrange this. The normal requirements for reporting adverse reactions and defects apply to PLPI products. MHRA does not consider trademark infringements when granting parallel import ( PLPI) licences. You must be entitled to use the name of your product and it must not infringe on trademarks. If you are granted a licence, you will still need to comply with any other statutory provisions or any private civil rights of third parties. If your product is controlled by the Misuse of Drugs Act you will need an import licence from the Home Office. To assemble and repackage the product you will also need to have an manufacturer’s licencecovering product assembly.
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