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Registration

registracijeProfessional team of BONIFARM bases its expertise in regulatory affairs on long experience in the development, preparation and harmonization of comprehensive documentation required for registration of medicines, medical products, food supplements and cosmetic products in accordance with Croatian and European legislation.

Our work is based on a consideration of the overall scientific, legal and business aspects, with the aim to ensure fast and reliable compliance with current legislation for our partners who develop, produce or distribute their products, and thus shorten and simplify putting their products on the market.

Scope of Regulatory Affairs

Bonifarm offers professional management of all regulatory activities related to medicines, medical devices, dietary supplements and cosmetic products, which include:

  • strategic planning of the medicine registration process (pre-registration activities)
  • registration of medicines in the area of Croatia and the EU
  • post-registration regulatory activities (modifications, renewals, approval of transfers etc.).
  • expert translations of Summaries of product characteristics, patient information leaflets and labelling, and other documentation on the medicine
  • conducting readability users tests (RUT)
  • obtaining a license for medicines and medical products wholesale
  • obtaining consent for entry / import of medicines and approval for exemption from labelling and patient information leaflets
  • registration of the manufacturer of the medical product in the register of medical products
  • registration of medicinal product in the register of medical products
  • the inclusion of dietary supplements in the monitoring program / obtaining notification number
  • obtaining electronic notification of cosmetic products through CPNP

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Medicines

  • Registration of medicines (National procedure and MRP/DCP procedure)

- Registration of new medicine

    • Collecting and preparation of documentation for registration
    • Professional translations of SPC, PIL and other documentation on medicine
    • Preparation of forms for application
    • Submition of complete request with the Regulatory agency
    • Permanent communication with the Agency until the final decision on registration

- Registration of homeopathic medicine

    • Collecting and preparation of documentation for registration
    • Professional translations of SPC, PIL and other documentation on medicine
    • Preparation of forms for application
    • Submition of complete request with the Regulatory agency
    • Permanent communication with the Agency until the final decision on registration

- Registration of allergens

    • Collecting and preparation of documentation for registration
    • Professional translations of SPC, PIL and other documentation on medicine
    • Preparation of forms for application
    • Submition of complete request with the Regulatory agency
    • Permanent communication with the Agency until the final decision on registration

- Registration of a traditional herbal medicine

    • Collecting and preparation of documentation for registration
    • Search in the professional literature and preparation of expert opinion
    • Preparation of necessary documentation
    • Preparation of forms for application
    • Submition of complete request with the Regulatory agency
  • Permanent communication with the Agency until the final decision on registration
  • Post-registration regulatory activities (changes, renewals, approval of transfers etc.)

- Registration renewal
- Changes in the approval for putting the medicine on the market (all chances included
- Approval of transfer

  • Strategic planning of the medicine registration procedure (pre-registration activities)
  • Possibility of working also in eCTD format

MEDICAL PRODUCTS

  • Manufacturer registration in the Register of producers of medical products
  • Registration of medical product in the Register of medical products

FOOD AUPPLEMENTS

  • Inclusion of food supplements in the monitoring program /obtaining the notification number

COSMETIC PRODICTS

  • Electronic notification of cosmetic products via CPNP