List of regulation services

We help you meet all of the requirements needed to successfully register your products.

Our services include all activities related to the registration of your products, such as services of medicinal products registration, renewal of registration and approval of amendments to the marketing of medicinal products, medical devices, foods for special medical needs and food supplements. These include:

• Evaluation of documentation/ dossiers
• Dossier preparation
• Liaison with health authorities
• MAH applications
• Registration
• Client advising
• New product submissions and follow up till approval for innovative and generic products
• Post-approval support

• Renewal of registration
• Variations
• Labeling
• Post-marketing regulatory support
• Line extensions for additional indications/uses, QA, Qualified Person, import issue resolution etc.
• Preparing proposals texts of inner and outer packaging

in accordance with legal requirements
• Translation and preparation of draft texts of PIL and summary in accordance with legal requirements
• Communication with the relevant Competent Authority
• Other documentation preparation and translation services
• Archiving registration documents

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We offer services to subjects in food operations in the process necessary for the marketing of food supplements, i.e. in obtaining a decision on the application to the monitoring program.

What are food supplements?

Food supplements are preparations manufactured from concentrated sources of nutrients or other substances with a nutritional or physiological effect with the purpose of enriching normal diet:
• Nutrients – vitamins and minerals
• Other substances – amino acids, essential fatty acids, fiber, plants, plant extracts, microorganisms, edible fungi, algae, bee products and others

Regulation of food supplements

The composition of food supplements must be in accordance with the relevant Law, Acts and Ordinances related to food and food supplements. For certain substances listed in Annex I, prescribed criteria of purity apply, and for substances for which purity criteria has not yet been prescribed, general purity criteria recommended by international bodies apply.

Labeling of products

• Properties of prevention, treatment and cure of disease cannot be attributed to the product, nor is it possible to refer to such properties (e.g. eliminating problems caused by diabetes, for healthy joints, to reduce cholesterol etc.)
• It should not contain statements implying that a balanced and varied diet cannot provide appropriate quantities of nutrients

Our service includes:

• Declaration writing and label design for food and food supplements
• Notification of food supplements in the SISSI portal
• Notification of foods for special needs
• Communication with the Ministry of Health
• Development of new food supplements based on client’s ideas and preferences (mediator between suppliers and manufacturers) – from idea to product on the shelf!

The subject is required to match the text labeling of food supplements with the Ordinance on Food Supplements and other relevant regulations.

If you have additional questions, please
contact our Regulatory Department.

If you have additional questions, please
contact our Regulatory Department.

Contact us

Headquarters

Lašćinska cesta 40
HR-10000 Zagreb
Croatia

Office

Planinska ulica 13/2
HR-10000 Zagreb
Croatia

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
info@martifarm.com

Pharmacovigilance

farmakovigilancija@martifarm.com
Tel: +385 1 5588 297

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Legal info

Full company name
Short company name
Headquarters
Office
Legal form
Court register
Registration number

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
080751121

 

OIB
Share capital
Authorized representative

29969122438
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)

 

Bank account

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

OIB: 29969122438
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)

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