News Category: Regulatory news
On 20 April 2022, Directive 2022/642/EC of the European Parliament entered into force. This Directive amends Directives 2001/20/EC and 2001/83/EC regarding derogations from certain obligations concerning certain medicinal products for human use made available in the United Kingdom in respect of Northern Ireland, and in Cyprus, Ireland and Malta. The objectives of amending Directive 2022/642/EC are to facilitate continued supply of medicinal products and to maintain a high level of public health protection. In order to ensure uniform application of Union law in all Member States, the derogations applicable in Cyprus, Ireland and Malta will apply until 31 December 2024.
To ensure transparency, the Directive stipulates that the competent authorities of Cyprus, Ireland and Malta and the United Kingdom in respect of Northern Ireland publish on their website a list of the medicinal products marketed to which these derogations have been granted.
The HPRA has compiled the list of products availing of the derogations as permitted in Directive 2022/642/EC. Products are identified by product name, PA number and MAH. This list is required to be updated on at least a six-monthly basis.
MAHs to whom derogations have been granted are required to check the details of this list below and to contact the HPRA at email@example.com when a particular derogation is no longer required, specifying which derogation is no longer needed. When full regulatory compliance has been achieved, please contact the HPRA and the product can be removed from the list. Please note that products on the list must not be onward supplied outside of IE.
Applicants must fill in a justification template outlining their request for a justifiable case, in order to proceed with a variation/new application which includes a UK (GB) site on a licence. Where the HPRA agrees to such a justification, the HPRA will revert with the completed template which must then be included by the applicant in their submission to the RMS (in Module 1).
After approval of the relevant new application/variation procedure and at the time of marketing of the new product in IE or for existing products, a second step is required to formally request a derogation from the HPRA and to include this product on the published list held by the HPRA.
*These forms were published on 14 June 2022.