Introduction to regulation of cosmetic products
According to Regulation 1223/2009 on cosmetic products, a cosmetic product is any substance or mixture intended to be placed in contact with the external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance, protecting them, keeping them in good condition or correcting body odours.
Cosmetic products include a broad spectrum of pharmaceutical forms, such as creams, gels, powders, soaps etc., and it should be stressed that all product features must be taken into account for its categorisation, since cosmetic products may also be subject to regulations relating to medicinal products, medical devices and biocides.
Marketed cosmetic products must be manufactured in accordance with good manufacturing practice and should be safe in normal or reasonably foreseeable conditions of use. In order to demonstrate that a cosmetic product complies with these conditions, the qualified person must ensure that product safety assessment is performed by a formally qualified person.
In addition, the qualified person must maintain the product information file (PIF) after product marketing and notify the competent authority of any undesirable effects occurred during product use.
Prior to cosmetic product marketing, it is required to notify the product in CPNP (Cosmetic Products Notification Portal) to ensure product monitoring. Products containing substances classified as carcinogenic, mutagenic or toxic to reproduction or substances in the form of nanomaterials are monitored in particular.
Iva Jurković Tretinjak, MPharm / Regulatory Affairs Associate
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)