Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)
The process to convert Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs)
Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs)
The UK has in place arrangements for the continued authorisation of medicinal products.
Great Britain
Parallel Distribution Notices are no longer valid in Great Britain (England, Scotland, Wales) and are replaced by Parallel Import Licences which allow the products to be marketed in Great Britain only.
This guidance provides a detailed description of the process we have put in place to convert your Parallel Distribution Notices (PDNs) into Parallel Import Licences (PILs) for Great Britain at the end of the Transition Period.
Northern Ireland
Parallel Distribution Notices will remain valid in Northern Ireland and no regulatory action is required to continue to market products directly imported from EU into Northern Ireland only.
Outline of the process for converting PDNs to PILs
PDN鈥痟olders are given the opportunity to opt-in to the conversion process for all or some of their鈥�PDNs鈥痓y notifying the MHRA in writing as described below. This process requires minimal information from鈥�PDN鈥痟辞濒诲别谤蝉.
If you choose not to opt-in, your product(s) will no longer be licensed in Great Britain and you will no longer be able to place them on the market in Great Britain.
MHRA鈥痺ill allocate Product Licence (PL) numbers to鈥�PDNs based on the existing practice for determining how many separate national licences are needed across a product range. All pack sizes will be covered by a single鈥�PL鈥痭耻尘产别谤.
PILs鈥痺ill be valid for a single source country and a separate鈥�PIL鈥痺ill be issued for each source country you request.
There is no fee associated with the conversion from a PDN to a Great Britain PIL. However, a periodic fee of 拢307 will be due on 1 April 2021 for each PIL requested unless a request to cancel the PIL on 31 March 2021 has been notified to MHRA ([email protected]) no later than 31 December 2020.
This is consistent with current periodic fee conditions.
Detailed description of the process for converting鈥�PDNs鈥痶辞鈥�PILs
Actions to take if you are a PIL holder
PILs鈥痑re being issued as a replacement for鈥�PDNs鈥�(which will no longer be valid in Great Britain) and will be issued to the holder of the鈥�PDN.
罢丑别鈥�PDN鈥痟older will need to have a company number allocated by鈥�MHRA鈥痑s this forms part of the鈥�PL鈥痭umber which will be allocated to each鈥�PIL.
If you do not already have a鈥�MHRA-allocated company number please 肠辞苍迟补肠迟鈥�[email protected] as soon as possible for instructions on how to apply for a number.
PIL鈥痟olders will need to be established in the UK. If you are a鈥�PDN holder not established in the UK, but you have an associated company established in the UK which you would like to be the holder of your鈥�PILs,鈥痯濒别补蝉别 肠辞苍迟补肠迟鈥�MHRA鈥痑s soon as possible to make this arrangement.
If you do not have an associated, UK-based company you will need to notify MHRA before the end of a period of 4 weeks from the end of the transition period of the name, address, telephone number and email address of an individual who resides and operates in the UK and who may be contacted in respect of any matter relating to the PIL.
You will also need to establish a company in the UK before the end of a period of 24 months from the end of the transition period.
Contact MHRA as soon as this company has been allocated a number by MHRA and we will transfer your PILs to the new company for no fee.
How to opt in
PDN鈥痟olders have been provided with a list of鈥�PDNs understood to be valid on 31 December 2018. This list was updated before the end of the transition period.
Check this list very carefully and please notify MHRA of any discrepancy.
厂辞尘别鈥�PDNs鈥痳efer to鈥�EU鈥痩icence numbers which are not listed in the current product information available on the EMA website. These presentations may no longer be valid and鈥� PILs鈥痺ill not be issued for them unless you specifically request one.
The list includes a column for the source countries you want to use for each product. A separate鈥�PIL鈥痺ill be issued for each source country you request. If you do not want your 鈥�PDN鈥痜or any product converted to a鈥�PIL, please enter 鈥渘one鈥� in this column.
Return the completed list as soon as possible to鈥�[email protected].
You must return the list no later than 21 days after the end of the transition period if you wish to take part in the conversion process. It will not be possible to convert further PDNs after the end of this 3-week period and a fresh application for a parallel import licence would be necessary, with the associated fee payable.
How to request further information for companies involved in repacking
PILs鈥痳equire some additional information about the companies involved in the repacking process, including the supplier from whom the product is obtained and the companies involved in importing, repacking, batch release, storing and distributing the product.
Supplier information should be addressed by completing a 鈥渟upplier commitment鈥�, signed by a director of the Parallel Importing company. This is a commitment by the importing company to confirm validity of authorisations (e.g. WDA) and to record details of the source of each batch of product repacked. For details of the wording required, please 肠辞苍迟补肠迟鈥� [email protected]. This commitment must be returned before any鈥�PIL鈥痭umbers can be issued and no later than 4 weeks after the end of the transition period.
Companies involved in repacking are best managed using a 鈥淐ompany Functions List鈥�. This can be updated at any time by submitting an updated list to鈥�[email protected]. The latest list will be applied when a new鈥�PIL鈥痠s granted. Please contact [email protected]鈥痜or a template and example document. This information must be returned before any鈥�PIL numbers can be issued and no later than 4 weeks after the end of the transition period.
Issue of PL numbers
As soon as possible after receipt of the list of鈥�PILs鈥痽ou require,鈥�MHRA鈥痺ill return an updated list which includes a鈥�PL鈥痭umber allocated to each product/source country requested.
After the end of the transition period
Immediately after the end of the transition period you may continue to repack and release those products for which you have requested a鈥�PIL鈥痷sing labels and leaflets consistent with the latest annex on the鈥�EMA/EC鈥痺ebsite and carrying the鈥�EU鈥痩icence number.
Products for which you have not requested a鈥�PIL鈥痬ay not be released after the end of the transition period.
Once you have received your list of鈥�PIL鈥痭umbers you should update the labels and leaflet to use these numbers as soon as practicable.
You should continue to monitor the鈥�EMA/EC鈥痺ebsite and update the labels and leaflet used in your released product to remain consistent with the latest annex on the鈥�EMA/EC website.
Receipt of PILs
We expect that it will take some months to issue all of the鈥�PILs鈥痳equired. They are likely to be produced on a 鈥榖y product鈥� rather than a 鈥榖y importer鈥� basis.
罢丑别鈥�PILs鈥痯roduced may use a substitute UK reference MA to allow cases to be created in our licence management system before the relevant UK MA for the reference product has been issued. A change of UK reference product variation will be applied to each PIL by MHRA at no fee at a later date.
罢丑别鈥�PILs鈥痯roduced as part of this process will use the鈥�EMA/EC鈥痑nnexes for the label and leaflet documents. No 鈥渦ser test鈥� of the patient leaflet will be required.
PIL maintenance
Once a鈥�PIL鈥痜or a converted product is issued the established Parallel Import variation process applies. Variations should be submitted and approved before an affected product is released, unless the change falls within the Tell-and-Do scheme. Scans of samples should be submitted when required.
The first variation affecting labels and/or leaflets must be accompanied by a mock-up of the respective document(s). In the case of labels this must begin with the label summary sheet. Please contact [email protected] for a template.
Contact
For further information, please email our Customer Services Centre at [email protected]. You can also email [email protected] with urgent questions. Alternatively, contact your Trade Association by emailing:
- Association of the British Pharmaceutical Industry (ABPI): [email protected]
- British Generic Manufacturers Association (BGMA): [email protected]
- BioIndustry Association (BIA): [email protected]
- Clinical & Contract Research Association (CCRA): [email protected]
- Ethical Medicines Industry Group (EMIG): [email protected]
- Health Food Manufacturers鈥� Association (HFMA): [email protected]
- The National Pharmacy Association (NPA): [email protected]
- Proprietary Association of Great Britain (PAGB): [email protected]