**** 2014 UPDATE ****Wholesale Distribution Authorisation holders – Regulatory Support
So you’ve made it to this page and here is our 2014 update.
We often receive enquiries regarding the type of authorisation or licence required from the MHRA to trade in medicines within Europe and globally and what is required to obtain the authorisation or licence. Although PCL advise on an individual basis, as each business is unique, here is an outline of which authorisation or licence is required for certain activities:
WDA(H) – Wholesale Distribution Authorisation (Human medicines) enables the trader to distribute medicines within the EU and export the categories of medicines listed on their authorisation. WDA(H) holders will need to employ or engage the services of a Responsible Person ((RP).
Manufacturer’s ‘Specials’ Licence enables the holder to import small quantities of unlicenced medicines from outside the EU. The MHRA must be pre-notified of the intention to import specials. The MHRA does have the right to refuse import permission either if a UK licensed alternative becomes available, or if the unlicenced medicine does not fully comply with strict manufacturing controls. Holders of a specials licence will also require the services of an RP.
MIA enables the holder to import licenced medicines from outside the EU. An MIA holder will need to employ or engage the services of a Qualified Person (QP) who both approves the overseas manufacturing plant and is responsible for the batch release of the product within the UK. The additional work required to be undertaken by the QP will add considerably to the cost of obtaining an MIA.
Controlled Drugs (CDs) The licence for controlled drugs is issued by the Home Office. Premises where controlled drugs are stored will need to meet the strict security measures as stated by the Home Office.
PCL can advise you on your specific needs, the regulatory requirements and can act as your contract RP.
Do you have an opportunity to discuss?
Do you need some answers?
Give us a call on 01252 302342 and one of our RPs would be glad to help.
**** END UPDATE ****
New Wholesale dealer’s license (WDL) applicants and holders are often unclear of which type of license they need to obtain from the MHRA and what level of regulatory support and advice the MHRA expect each type of license holder to have at their service to advise them.
For licensed human medicines, a standard WDL allows the holder to import from within the EEA and to export the categories of medicines applied for on the license application, and to distribute them within the UK by wholesale dealing. The license holder must employ or engage the services of Responsible Person (RP) who takes legal responsibility for the companies distribution activities. (Naturally there are additional controls on Controlled Drugs (CD) and on medicines that have to be kept refrigerated)
If the wholesaler wishes to import small quantities of unlicensed medicines from outside the EEA, a Manufacturer’s Specials version of a WDL is required, and the regulatory support of an RP is still required. Also, on each occasion unlicensed medicines are to be imported, the MHRA must be pre-notified in advance of the intended importation, on a special form. The MHRA does have the right to refuse import permission either if a UK licensed alternative becomes available, or if the unlicensed medicine does not fully comply with strict manufacturing controls on ingredients, particularly those that may have “BSE like” risks.
To the surprise of many, the import of licensed medicines from outside the EEA , not only requires yet a different version of an WDL (called an MIA) but also requires the license holder to employ or engage the services of a Qualified Person (QP) to both approve the overseas manufacturing plant/s and also to take responsibility for the batch release (and if required recall) of the products within the UK. The additional work required to be undertaken by a QP, will add considerably to the cost of both obtaining and retaining an MIA type of WDL. It is perhaps for this reason that most MIA WDL holders often tend to be larger companies, with a portfolio of products, who therefore are more likely to have the financial resources to cover the costs of employing or engaging the services of a QP.
Pharmacy Consulting Ltd offers contract RP services to a small number of UK medicines wholesalers.