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
What are cosmetic products?
A cosmetic product is any substance or preparation intended to be placed in contact with the various external parts of the human body or with the teeth and the mucous membrane of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or protecting them or keeping them in good condition.
Regulation of cosmetic products
The main aspect of the regulatory compliance of cosmetic products in the EU is that it is the responsibility of the manufacturer or importer to ensure that the cosmetic products meet all requirements of the Cosmetics Regulation.
Our service includes:
- Consulting clients on current laws and regulations
- Review of existing documentation and reference to registration if needed
- Declaration writing and label design for cosmetic products
- Safety assessment writing
- Mediator between clients and accredited laboratory for cosmetic products
- Notification of cosmetic products in the CPNP portal
If you have additional questions,
please contact our Regulatory Department.
If you have additional questions, please contact our Regulatory 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)