On October 12st 2018, the HPRA issued an update to its guidance on Notification of Marketing Status of Human Medicines. The update to version 4 of this guidance is available by clicking the link below.
The main change from version 3 to version 4 is that the HPRA have clarified their expectations for notifying them in cases where there is a temporary cessation of marketing a medicinal product which may result in a shortage in supply. It is expected that the MAH notifies the HPRA Shortages Unit by completing the ‘Notification of Medicinal Product Shortage from Marketing Authorisation Holders’ form (available in the link below), and returning it electronically to email@example.com and to the Health Service Executive Corporate Pharmaceutical Unit at CPU@hse.ie.
The remainder of the guidance remains largely unchanged with the main points summarised below:
- Upon obtaining a Product Authorisation, the PA holder must notify the HPRA of the date that the product was actually marketed, and also notify the HPRA no less than two months in advance of a (temporary or permanent) cessation in marketing.
- Companies should notify the HPRA of products that have never been marketed, so that annual maintenance fee invoices are correct.
- When a decision is taken to no longer market a product and there is no other therapeutic alternative, notification must be given to the Department of Health 12 months in advance of the intended date of cessation of marketing.
- There is a distinct difference between cessation of marketing (temporary or permanent) and the total recall of all batches from the market, where the latter is handled through the Compliance Department of the HPRA.
- The ‘sunset clause’ applies to products which are not marketed for three consecutive years, where:
The authorisation or certificate ceases to be valid if the product is either not marketed at all for a period of three consecutive years or is marketed but marketing ceases for a period of three consecutive years…The HPRA may grant exemptions from the three-year rule, if justified on public health grounds.
Examples are provided where exemptions to the sunset clause would be accepted by the HPRA:
- Critical medicinal products which are only produced when needed, e.g. vaccines
- Medicinal products which are required in an emergency public health crisis
- Medicinal products under litigation, or where the authorisation or use is suspended.
The main exception to the sunset clause is for generics of reference products where the application for the reference product was made after 23 July 2007. For these products, the three-year period begins when the market exclusivity period for the reference product expires. This is 10 years from the date of authorisation of the reference product, or 11 years if an extension is granted for an indication for which significant clinical or non-clinical studies were provided.
In the context of the sunset clause, the authorisation or certificate will remain valid if at least one pack format (size, strength, pharmaceutical form) is marketed.
- The PA holder and distributor are reminded of their obligations, within the limits of their responsibilities, to ensure appropriate and continued supply of medicinal products.
If you would like further information or wish to discuss how PharmaLex can support you with queries on the Marketing Status of Human Medicines, please connect with us at +353 1 846 4742 or firstname.lastname@example.org.