The Regulatory and Scientific Advice Office (GARC) aims to advise on requests to INFARMED, I.P. or to other entities with similar competences in accordance with current regulatory, legislative and scientific requirements, allowing their validation and evaluation to be carried out in an expeditious manner.

GARC is responsible for clarifying issues arising from the preparation of documents relating to: Clinical Trials, Marketing Authorization (AIM), changes to AIM’s terms, Renewals of AIM for Medicines for Human Use or any other subjects related to them; CE marking, or procedures complementary to the CE marking; Notification and registration of Medical Devices and Cosmetic Products; Licensing of entities and good practices.

Advice can be sought during initial development stages of medicinal products, medical devices and cosmetic products (pre-submission) and also during post-marketing.  However, advice cannot be sought after submission of an application for marketing authorisation, clinical trials or request for EC marking.

No, its area of expertise is limited to scientific   and academic community, entities and professionals working in the area of pharmacy, medicine, cosmetics and medical devices, whether clinical or pre-clinical.

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) (cimi@infarmed.pt).

 

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.

• Questions on scientific advice may be related to, but not limited, the following areas:
• Pharmaceutical
• Pre-clinical / Clinical (clinical evaluation / clinical trials)
• Pharmacokinetics
• 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
• Licensing
• Surveillance / Risk management
• Media advertising
• Assessment of conformity / procedures
• Design / Manufacturing / Quality control / Post-market control system

The opinion issued by GARC neither bind nor oblige INFARMED, I.P. in its final decisions on the related processes.
The advice provided does not replace the responsibilities of applicants and / or individuals regarding products, processes and associated activities.

• 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.

GARC is supported by a network of internal and external experts with the regulatory, specific and necessary knowledge, experience and qualification, including the Specialized Technical Commissions.

GARC is organized in accordance with the ISO 9001 standard. In compliance with the standard, audits of GARC processes are carried out periodically. It is an integral part of the procedure, filling out an evaluation questionnaire, after each advice, with the primary objective of continuous improvement of the system and consequent satisfaction of our customers.

After receiving the request for advice, via e-mail (garc@infarmed.pt), 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.

According to the Portuguese Administrative Procedure Code (Código do Procedimento Administrativo), the deadlines count as working days.

There is a fee payment for regulatory and scientific advice, which varies depending on the aim, field and scope of the advice. Please see Guide for regulatory and scientific advise (RSA).

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.