Discounts available to marketing authorisation holders registering now
(April 24th, 2018) Generic manufacturers are being urged to register now with SecurMed UK - the Medicines Verification Organisation - to ensure that the UK repository is in place when the verification parameters of the Falsified Medicines Directive (FMD) come into effect in February next year.
SecurMed UK has written to all marketing authorisation holders (MAHs), including generic companies, urging them to register and pay the fee required to ensure compliance with FMD, and the associated Delegated Regulation.
The directive places a duty on medicines manufacturers and marketing authorisation holders to fund and develop a repositories system which enables the authentication of medicines, based on the safety features applied to each pack.
These measures will ensure easier identification of falsified medicines, and their verification. Medicines under the responsibility of marketing authorisation holders which have not contributed to the establishment of the verification system risk regulatory enforcement measures.
Warwick Smith, Director General of the British Generic Manufacturers Association (BGMA), said: “It is imperative that companies register and pay fees promptly to SecurMed UK, thus enabling the creation of the UK repository, so that they and other stakeholders can meet their regulatory obligations and compliance with the Delegated Regulation. This is not something which can be left to the last minute otherwise there is real risk to disruption in medicines supply.
“Marketing authorisation holders need to sign-up now and pay the set-up fee. Companies doing this before the end of May will receive a discount of over 50% from the basic fee.”
The Government has recently confirmed its intention to implement EU obligations including laws made to implement the Falsified Medicines Directive and has confirmed that the duties under the
Delegated Regulation will continue to apply unless specifically revoked.
For further information contact Jeremy Durrant on 02078667883 / 07792918648 or email email@example.com