What is marketing authorisation renewal and how to obtain it?
The regulatory journey of your product does not end with its placement on the market: regular marketing authorisation renewals are also required for safety profile monitoring to ensure health of product consumers.
A marketing authorisation (MA) is valid for five years. The MA may be renewed upon application by the marketing authorisation holder (MAH) to the Agency for Medicinal Products and Medical Devices of Croatia (HALMED) for each pharmaceutical form and product strength at least nine months before its expiry.
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:
- Application for marketing authorisation renewal in Croatian and English
- European Commission (EC) renewal application form in Croatian or English
- Module 1.2 Application Form – European Union (EU) electronic application form (eAF)
- Module 1.3.1 Summary of product characteristics (SmPC), package leaflet and labelling
- Module 1.3.2 Mock-up
- Module 1.4 Information about the experts
- Module 1.8.2 Risk management plan (RMP)
- Module 2.4 Addendum to non-clinical overview
- 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.
Ana-Marija Turčić, DVM / Registration Associate
Lašćinska cesta 40
Planinska ulica 13/2
Ured: +385 1 5588 297
Farmakovigilancija: +385 1 5588 297
Klinička ispitivanja: +385 1 5614 330
Registracija: +385 1 2420 873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
Tel: +385 1 5588 297
Full company name
Short company name
Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)
HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)
Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)
Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)