New UK procedures for obtaining parallel trade licences kick in on 7 June
This article was originally published in SRA
The UK Medicines and Healthcare products Regulatory Agency has issued a best practice guidance document that parallel importers of medicinal products must conform to from 7 June when submitting their licensing submissions1.
The document, published on 14 May, lists the “common deficiencies” that the MHRA comes across in licensing submissions made by parallel importers of drugs and explains how to overcome them to ensure that the submissions are of a high standard. Submissions that do not conform to the procedures laid down in this best practice guide from 7 June will be considered invalid and rejected by the MHRA. The reasons for invalidation will be provided to the applicant, who must then resubmit the application in its entirety after addressing the deficiencies.
The agency says that poor quality or incomplete submissions cause delays with regard to its ability to process and assess parallel import submissions. These delays, it adds, affect not only the companies that send poor quality submissions; they also have a knock-on effect on companies providing high quality submissions as resources have to be diverted to problem areas. It is thus adopting a strict approach to the management of submissions for product licence for parallel import (PLPI). Once an application has been made, the MHRA says there will be no further contact between the agency and the applicant during the validation process.
Based on the MHRA’s experience of handling of PLPI submissions, the problems affecting these applications can broadly be classified into two types: pertaining to the formatting and completeness of the document set; and the provision of “proof of payment” of capital fees at the time of submission.
Grace period
Though the requirement to pay capital fees “at the time of application” is mandatory under the MHRA Fees Regulations, the agency acknowledges that this may represent a change to the current work practices of some parallel import traders, which have become accustomed to paying the fee on subsequent receipt of an invoice.
Therefore, between the date of release of the guidance and 7 June, the MHRA is allowing an interim period during which submissions (not complying with this specific requirement only) will not be rejected immediately. Under this, companies will be contacted individually and provided with an extended grace period to rectify the deficiency.
However, the provision for the interim period will end on 7 June. Thereafter, all PLPI submissions must be accompanied by a “proof of payment form”2, available on the MHRA’s website. The submission of the completed form, the agency says, will demonstrate compliance with the requirement that the fee has been paid at the time of the application.
Submission format
While PLPI submissions can be made using the “special MAIL 5” format, the MHRA is advising companies to provide submissions in electronic Common Technical Document (eCTD) or non-eCTD electronic submission (NEES) formats “as it is likely that this will be a future mandatory standard”.
The PLPI guidance also describes the special requirements for the submission of labels and leaflets. The labelling components, such as carton, blister label and Braille over labels, it says, should be merged into a single PDF document and not submitted as separate documents.
When submitting a variation, it is acceptable to add Braille to the over-label and carton with other changes to comply with the requirements under the amended medicines legislation (Directive 2001/83/EC). Companies dealing with parallel import products that are subject to an existing parallel import licence have until 30 October 2010 to comply with the Braille requirement.
References
1. MHRA, Parallel Import applications – Guidance to Best Practice, 14 May 2010, www.mhra.gov.uk/Howweregulate/Medicines/Medicinesregulatorynews/CON081922
2. MHRA PLPI Proof of Payment form, 14 May 2010, www.mhra.gov.uk/home/idcplg?IdcService=GET_FILE&dDocName=CON081918&RevisionSelectionMethod=LatestReleased