Falsified Medicines Directive: MHRA Responds to Comments, Addresses Brexit Impact
Regulatory News | 08 January 2019 |
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) last month responded to comments on its proposal to implement packaging safety features under the EU Falsified Medicines Directive (FMD).
The safety features, which include requiring a unique identifier comprised of a 2D data matrix code and human readable information and an anti-tampering device on the packaging of certain medicines, are detailed under Commission Delegated Regulation (EU) 2016/161.
The public consultation was launched in July 2018 and received more than 50 comments.
MHRA says the responses "broadly supported the government's proposed positions," though some commenters raised concerns over the government's proposed approach to certain flexibilities allowed for under the Delegated Regulation.
In particular, MHRA says it will change its approach to allow an exemption for persons within healthcare institutions to decommission unique identifiers under certain circumstances. Initially, MHRA did not plan to allow for the exemption, but now says it sees some practical benefit to the exemption.
"We now understand that many [National Health Service] NHS hospital Pharmacy Departments do hold warehouse and distribution agreements (WDAs). Allowing the Article 26(3) exemption may provide some hospitals with additional flexibility, especially for those hospitals which have many different and geographically separate facilities or sites," MHRA writes.
In its response, MHRA says it will allow for the exemption, so long as:
Brexit
MHRA also addressed how the FMD will apply once the UK exits the EU on 29 March 2019. As the UK will still be a member of the EU on 9 February 2019 when the FMD takes effect, MHRA says that its requirements will be applicable to the UK on that date.
According to MHRA, FMD would fall under the 21-month implementation period proposed in the draft Brexit withdrawal agreement released last November. However, it is still unclear whether the UK Parliament will back the withdrawal deal.
"In the event that the UK leaves the EU in March 2019 with no deal in place, and as stated in the agency's broader consultation … we expect that the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK," MHRA writes.
As a result, MHRA says that the legal obligation to follow the FMD would not apply to products within the UK, though the agency says it would still allow products with FMD safety features so long as they are also in compliance with UK packaging requirements.
In the event of a no-deal Brexit scenario, MHRA says it will look into developing a national falsified medicines framework in the future.
MHRA
The safety features, which include requiring a unique identifier comprised of a 2D data matrix code and human readable information and an anti-tampering device on the packaging of certain medicines, are detailed under Commission Delegated Regulation (EU) 2016/161.
The public consultation was launched in July 2018 and received more than 50 comments.
MHRA says the responses "broadly supported the government's proposed positions," though some commenters raised concerns over the government's proposed approach to certain flexibilities allowed for under the Delegated Regulation.
In particular, MHRA says it will change its approach to allow an exemption for persons within healthcare institutions to decommission unique identifiers under certain circumstances. Initially, MHRA did not plan to allow for the exemption, but now says it sees some practical benefit to the exemption.
"We now understand that many [National Health Service] NHS hospital Pharmacy Departments do hold warehouse and distribution agreements (WDAs). Allowing the Article 26(3) exemption may provide some hospitals with additional flexibility, especially for those hospitals which have many different and geographically separate facilities or sites," MHRA writes.
In its response, MHRA says it will allow for the exemption, so long as:
- "The person authorised or entitled to supply medicinal products to the public obtains the medicinal product through a wholesaler belonging to the same legal entity as the healthcare institution;
- The verification and decommissioning of the unique identifier is performed by the wholesaler that supplies the product to the healthcare institution;
- No sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution; and
- The medicinal product is supplied to the public within that healthcare institution."
Brexit
MHRA also addressed how the FMD will apply once the UK exits the EU on 29 March 2019. As the UK will still be a member of the EU on 9 February 2019 when the FMD takes effect, MHRA says that its requirements will be applicable to the UK on that date.
According to MHRA, FMD would fall under the 21-month implementation period proposed in the draft Brexit withdrawal agreement released last November. However, it is still unclear whether the UK Parliament will back the withdrawal deal.
"In the event that the UK leaves the EU in March 2019 with no deal in place, and as stated in the agency's broader consultation … we expect that the UK would not have access to the EU central data hub, and therefore stakeholders would be unable to upload, verify and decommission the unique identifier on packs of medicines in the UK," MHRA writes.
As a result, MHRA says that the legal obligation to follow the FMD would not apply to products within the UK, though the agency says it would still allow products with FMD safety features so long as they are also in compliance with UK packaging requirements.
In the event of a no-deal Brexit scenario, MHRA says it will look into developing a national falsified medicines framework in the future.
MHRA
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