What is marketing authorisation renewal and how to obtain it?

How is marketing authorisation renewal performed in Croatia?

The marketing authorisation renewal procedure in Croatia is prescribed by the Medicinal Products Act («Official Gazette», No 76/13, 90/14 and 100/18) and the Ordinance on Granting Marketing Authorizations for Medicinal Products («Official Gazette», No 83/13, 28/20 and 32/21).

In case of a national procedure (NP), the MA renewal application must contain the name and address of the MAH and the name(s) of the medicinal product(s) as well as the corresponding MA number(s), whereas a template of the Coordination Group for Mutual Recognition and Decentralised Procedures – Human (CMDh) should be used in case of a mutual recognition (MRP) or decentralised procedure (DCP).

Documentation for marketing authorisation renewal

Clients often ask us what documents they need for marketing authorisation renewal. The marketing authorisation holder is obligated to enclose the following documents with the application for marketing authorisation renewal:
 

1. Application for marketing authorisation renewal in Croatian and English
2. European Commission (EC) renewal application form in Croatian or English
3. Module 1.2 Application Form – European Union (EU) electronic application form (eAF)
4. Module 1.3.1 Summary of product characteristics (SmPC), package leaflet and labelling
5. Module 1.3.2 Mock-up
6. Module 1.4 Information about the experts
7. Module 1.8.2 Risk management plan (RMP)
8. Module 2.4 Addendum to non-clinical overview
9. Module 2.5 Addendum to clinical overview

What does renewal assessment include and who implements it?

Depending on the type of procedure, renewal assessment is performed by: the Agency for Medicinal Products and Medical Devices of Croatia – HALMED (NP), the reference EU/EEA Member State (MRP, DCP) or the European Medicines Agency (CP).

The assessment includes:

• Assessment of important efficacy/safety data (risks) that have arisen in the period since the marketing authorisation until the renewal application.
• Assessment of all other data relevant to benefit-risk balance evaluation of the product concerned in the authorised indications.
• Assessment of product information in accordance with the current scientific knowledge.
• Conclusion on the benefit-risk balance of the product concerned in the authorised indications.
• Recommendation on the validity period of the renewal.
• Definition of measures to be implemented by the MAH following authorisation renewal, if applicable.

What obligations does the marketing authorisation holder have?

The marketing authorisation holder has an obligation to ensure that the product information is kept up to date with the current scientific knowledge. However, none of the changes introduced at renewal can substitute for the MAH’s obligation to update the marketing authorisation throughout the product’s lifecycle by variation application.

Based on the benefit-risk balance re-evaluation for the product, the opinion may be:

• Favourable, whereby the renewal is issued:
  • For an unlimited period – the benefit-risk balance remains positive.
  • For a five-year period – on justified grounds relating to pharmacovigilance, the authorisation cannot be granted for an unlimited period or withheld.
• Unfavourable, whereby the benefit-risk balance is negative, meaning that a potential risk to public health has been identified.

To learn more about the renewal process and your obligations as the MAH, contact us at bd@martifarm.com or read more about our Registration team at https://martifarm.com/registration/.

Ana-Marija Turčić, DVM / Registration Associate