What is the Regulatory and Scientific Advice Office (GARC)?
Which is the mandate of GARC?
What is the scope of the advice to be provided by GARC?
Does GARC reply and informs the common citizens?
As a member of the general public, to whom must I send upcoming doubts or ask for information?
Infarmed’s website displays all available information on the rational use of medicines, the correct use of medical devices and cosmetics (PT).
You can also contact our Information Centre for Medicines and Health Products (CIMI) (firstname.lastname@example.org).
I fulfill GARC’s scope and I need advice. How should I proceed?
Submission and Validation
To submit a request, you must acknowledge all available information on Infarmed's website as well as our online guide. Finally, fill in the applicable form that is also available online.
What type of questions may I address?
- Questions on scientific advice may be related to, but not limited, the following areas:
- Pre-clinical / Clinical (clinical evaluation / clinical trials)
- Good Practices
- Methodological issues (statistical tests of use, data analysis, modelling and simulation).
- Product classification / Borderliners: Medical devices / Medicines or medical devices / Other
- Clinic (clinical evaluation / Clinical trials) / Toxicological
- Risk Management and Pharmacovigilance
- Surveillance / Risk management
- Media advertising
- Assessment of conformity / procedures
- Design / Manufacturing / Quality control / Post-market control system
Opinion, what do I must consider?
The advice provided does not replace the responsibilities of applicants and / or individuals regarding products, processes and associated activities.
- What kind of counselling formats are possible?
- Per face-to-face or virtual meeting - usually scheduled, at most, up to 30 days, after validation;
- Request Written Advise - Issued up to a maximum of 60 days, after validation.
Quality Assurance, Supervision and Control
Which deadlines should we consider?
After receiving the request for advice, via e-mail (email@example.com), the analysis and pre-validation takes place up to about 10 working days.
Regarding remaining timelines, consider the Guide for regulatory and scientific advise (RSA). When necessary, the times are adjusted considering the applicable variables and the interest of the parties involved.
There is no provision for the payment of fees for health products.
For medicines a duly justified request for fee reduction expressed in the submission form may be granted on grounds of interest for public health and company status, subject to management approval.