Safety Feature for Medicinal Products for Human Use - FAQs
HPRA Product Information FAQs
(i) safety features are relevant only to certain medicinal products for human use (veterinary medicinal products are not within scope)
(ii) these FAQs are intended to assist marketing authorisation holders in submitting notifications to the HPRA relating to inclusion of safety features on their medicinal product
(iii) these FAQs should be read in conjunction with those published by the European Commission -https://ec.europa.eu/health/human-use/falsified_medicines_en
- Are safety features required on medicinal products which are not subject to medical prescription?
Answer: The inclusion of safety features on medicinal products that are not subject to medical prescriptions i.e. over the counter (OTC) products (with the exception of those listed in Annex 2 of Delegated Regulation (EU) 2016/161) is considered outside the scope of Delegated Regulation (EU) 2016/161 and should not be submitted for formal assessment. A unique identifier should not be placed on an OTC product. However, should the marketing authorisation holder (MAH) wish to place or retain an anti-tampering device on an OTC product this is considered to be at the discretion of the MAH who must ensure that the addition of the anti-tampering device does not affect any other aspect of the labelling e.g. readability, font size, appearance etc.
- Are safety features required for non-marketed medicinal products?
Answer: The MAH must notify the HPRA of the inclusion of the safety feature by way of an update to the QRD template for all authorised products, including non-marketed products (with the exception of those listed in Annex I of Delegated Regulation (EU) 2016/161). Marketed products must be updated before 9 February 2019, whereas non-marketed products do not need to abide by this timeline but must be updated prior to placing the product on the market.
- Are mock ups required to register safety features?
Answer: There is no requirement for mock ups to be submitted if the product information text (QRD template) is registered with the HPRA. The amended QRD template is sufficient. If any changes apart from registration of the safety features are made e.g. information deleted or font size amended, and these changes do not meet the list of minor amendments that do not require prior notification to the HPRA in section 10.3 of the HPRA Guide to Labels and Leaflets of Human Medicines, then mocks ups will be required.
If only mock ups are registered with the HPRA then updated mock ups will be required.
- Is it acceptable to register the safety features during a MA Transfer?
Answer: No. The MAH can notify the HPRA of the safety feature information during any other ongoing procedure (e.g. Renewal, Variation II, Variation IB, Variation IA) between now and 9 February 2019.
- How are safety features registered in the absence of any other ongoing regulatory procedure?
Answer: In the absence of an ongoing regulatory procedure the MAH must register the updated safety features by way of an Article 61(3) Notification. This notification must be submitted to the HPRA prior to the implementation date (09/02/2019), and preferably at least six months before the implementation date.
Can the safety feature be implemented before HPRA approval of the variation?
The HPRA has taken the approach in line with CMDh recommendations (Q6), that registration of safety features is a notification system only and applicants are not required to wait until official approval is received before implementing changes. This approach is in line with the process for type IA variations, provided that no other changes are made on the mock-ups at the same time and it has no impact on the overall readability of the mock-up . Where this is the case, you do not need HPRA approval of the variation to implement the safety features.
For further information please visit HMA webpage on FMD
- Is the national reimbursement number required to be included in the safety feature for the Irish market?
- Are there specific requirements for anti-tampering devices (aside from those listed in the 1.14 of the European Commission Q&A)?
Answer: The choice of anti-tampering device (ATD) is at the discretion of the MAH. The ATD is not assessed once it does not impede the legibility of the text on the outer carton. However, if the ATD is placed on the immediate packaging and affects the container closure system, information on the ATD and how it affects the container closure system are required in section 3.2.P.2.4 and/or 3.2.P.7 of module 3 and will be assessed.
- Can both a linear barcode and 2D matrix code be printed on packs of in-scope medicinal products after the 9 February 2019 deadline?
Answer: The inclusion of both barcodes is acceptable provided this does not negatively impact the legibility of the packaging text (as per 2.3 in European Commission Q&A).
- Can safety feature changes be implemented in advance of approval by the HPRA?
Answer: Implementation of safety feature information can take place before approval (independent of the procedure with which it is notified) in line with the process for type IA variations, provided that no other changes are made to the mock-ups and that inclusion of the safety feature has no impact on the overall readability of the mock-up. The MAHs still have to notify the relevant national competent authorities (NCAs) before the implementation date, 9 February 2019.
Please see the ‘CMDh clarifications on questions received on the implementation of the Falsified Medicines Directive’ for further information.
- Where can I find information on the safety feature requirements for Centrally Authorised Products?
Answer: The EMA is responsible for receiving notifications of the inclusion of safety features on the packaging of centrally authorised medicinal products. Please refer to the Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use on the EMA website or contact the EMA directly for further information.
- Is it acceptable for an MAH to submit a bulk application for all affected national authorisations to update the product information?
Answer: A bulk application for national authorisations is acceptable.
- Is it acceptable for safety feature information to be printed on product packaging in a broken line format?
Answer: Yes, this is acceptable in principle. However, it is vital that it is clear to all users as to what each abbreviation means. For clarity, the expiry date of the product is expected to be written in full when this information is included in the broken line format.
- What prefix should be printed before the product code? Is the term ‘GTIN’ or the term ‘PC’ preferred?
Answer: Either the term ‘GTIN’ or ‘PC’ may be chosen.