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 provide comprehensive service for PIL testing / RUT and Bridging reports with or without focus testing.

What are RUT and PIL?

Patient Information Leaflets (PIL) are a set of comprehensible information for the safe and appropriate use of medicinal products. PILs must undergo user testing to establish their readability (RUT).

Bridging Report

The term bridging is used to describe the situation where, because the leaflets are sufficiently similar in both content and layout, a successful user consultation on one leaflet can be used to demonstrate that another leaflet meets the requirements of Article 59(3) of the Council Directive 2001/83/EC.

Bridging report with focus

Bridging reports with focus testing have to be performed in case of a bigger difference between the two PIL’s. However, they do not require complete RUT and it is possible to do a shorter testing with a few questions that will cover the area of greatest discrepancy between the PILs

Our service includes:

 

  • Analysis of the current leaflet and preparation of evaluation questionnaires (standard to all leaflets and specific to the concerned medicinal product)
  • Planning of the testing methodology
    • Target populations
    • Number of patients
    • Availability of patients
  • Instructions to general practitioners
  • Collection of data
  • Statistical analysis of collected data
  • Report for the regulatory bodies (according to the recommendations of the Directive 2004/27/EC)
    • Product description
    • Test or consultation details
    • Questionnaire
      • Method
      • Choice of population
      • Language tested
  • Original and revised package leaflets
  • Summary and discussion of results
  • Conclusion

How is bridging done?

Since the design and layout of the information is crucial to how the information is used and understood, “daughter” PILs should be of the same design, layout and writing style as the “parent” PIL in order for the bridging to be successful. A bridging proposal is unlikely to be acceptable to the competent authority if this concept has not been adhered to.

Our bridging reports

Bridging reports can be included as part of a PIL testing package. We work within reasonable budgets, and meeting deadlines is a priority for us. We have a short delivery of 3 weeks to the final report, assuming the client is timely in responses to edits and milestones. We provide reports in English and other languages.

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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