What is bridging?
When is bridging done?
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.
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
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.
Bridging report with focus
Bridging report 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.
We can also provide assistance in the adaptation of the leaflets, creating of mock-up, focus testing and bridging test reports.Bridging reports can be included as part of a PIL testing package. Let us help you to decide which RUT process you need for your PILs.
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)