Everything about registering traditional herbal medicinal products
A traditional herbal medicinal product (THMP) is a herbal medicinal product whose safety and efficacy can be determined on the basis of evidence of its traditional use (a minimum of 30 years in the world, of which at least 15 years in the EU), and which meets other requirements stipulated by the Medicinal Products Act and the Ordinance on Granting Marketing Authorisations for Medicinal Products.
For THMPs, efficacy and safety are assumed on the basis of evidence of long-term use, while for herbal medicinal products they are based on scientific evidence.
The registration procedure for THMPs (i.e. traditional use registration) involves medicinal products that meet the following requirements:
- They have indications appropriate exclusively to traditional herbal medicinal products which, due to their content and intended use, may be used without a doctor’s supervision.
- They are intended for use exclusively in accordance with the indicated strength and dosage.
- They are intended for external or oral use or for inhalation.
- They have a period of traditional use.
- There must be sufficient information about the traditional use of the medicinal product, in particular evidence that the medicinal product is not harmful under the specific conditions of use, and that the pharmacological effects or efficacy of the medicinal product are likely based on the long-term use and experience.
The Community List, HMPC monograph, data on corresponding products, expert papers, articles from scientific journals, known Galenic formulations prepared in pharmacies, data on conducted studies etc. can serve as evidence of traditional use.
If a THMP also contains a synthetic active substance in combination with active substances of herbal origin, it is classified as a chemical medicinal product. Exemptions are THMPs which may contain vitamins and minerals of well-established use, whose activity facilitates the activity of the herbal active compounds contained within with regard to the labelled indications.
There are other products on the market that may contain substances of herbal origin (medicinal products, food supplements, cosmetic products etc.) that are not subject to strict regulations as is the case for medicinal products. A product cannot be re-categorised from a food supplement or cosmetic product to a herbal or traditional herbal medicinal product via a simplified procedure. All products that intend to be placed on the market as medicinal products must fully comply with all applicable regulations of the Republic of Croatia and the EU, whereby the requirements for medicinal products are much stricter than those for food supplements or cosmetic products.
The manufacturer of a medicinal product is obligated to obtain a manufacturing authorisation for medicinal products because a manufacturing authorisation for food supplements or cosmetic products does not meet the requirements that must be fulfilled in order to obtain a manufacturing authorisation for medicinal products. In this case, the product’s quality and development should meet the prescribed quality standards for medicinal products. Therefore, it is necessary to collect documentation on the medicinal product’s safety and efficacy.
Do you have a product of herbal origin that you intend to register, but are unsure whether it meets the requirements for traditional herbal medicinal products? Our registration team has experience in preparing documentation for traditional herbal medicinal products and can provide you with professional assistance throughout the registration process. Connect with us at email@example.com to see what steps you need to take to place your herbal medicinal product on the market.
Iva Antunović Kršić / Head of Registration Department
Lašćinska cesta 40
Planinska ulica 13/2
Office: +385 1 5588 297
Pharmacovigilance: +385 1 5588 297
Clinical trials: +385 1 5614 330
Registration: +385 1 242 0873
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)