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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Medicinal products and medical devices

Regulation

As applicable, registration requirement may relate to:
• The original medicinal product
• Equivalent (generic) medicinal product
• Hybrid medicinal products
• A medicinal product that has had a verified medical use in the EU and Croatia for at least 10 years
• Herbal medicinal products
• Traditional herbal medicinal products
• Biological medicinal products

Medical devices undergo a procedure of Conformity Assessment of Medical Devices, registration at the Register of Manufacturers and the Register of Medical Devices.

Our service includes:

• Consulting clients on current laws and regulations
• Expert scientific, technical and medical translation
• Submission of registration dossier for a marketing authorization (MA) of a finished medicinal product in the name of a client
• Submission for renewal of marketing authorization of a medicinal product, or changes of marketing authorization, or changes to the product documentation
• Application for the registration of medical devices in the Register of Medical Devices
• Technical file preparation
• The application is submitted along with the data and documents in accordance with the Act and the Regulations on the procedure and method for granting marketing authorization for medicinal products, depending on whether it is a registration, renewal or variation of approval
• Continuous monitoring during the registration process until the solutions for marketing authorization / registration in the register of medical devices is obtained
• Devices require certification by a Notified body before manufacturers can label them with the CE mark. The technical file is an essential part of the technical documentation requested by a Notified Body
• The file must contain all information that is necessary to demonstrate the conformity of the product to the applicable requirements. Considerable attention is devoted to Risk Analysis and Clinical Evaluation

We communicate with the relevant regulatory body for medicinal products and medical devices on behalf of our clients.

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 2420 872
Registration: +385 1 2420873
Pharmacovigilance: +385 1 5588 297
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)