Regulatory framework

Recommended Prerequisites

It is recommended that student be able to read and understand tecnocal documents written in English.

Teaching Methods

Lectures with an appeal to student participation are combined with theoretical-practical exercises to simulate cases in a real context. Consultation practices and access to databases from European (EMA and EFSA) and national (Infarmed, DGAV, ASAE) regulatory authorities will be encouraged and guided.

Learning Outcomes

The student should get to know the principles and foundations of the European Union regulatory framework and respective transpositions into the Portuguese legislative order on:

- herbal medicines, in all relevant contexts to their production and access to the market, including the specificity of the simplified regimens supported by the demonstration of well-established use or traditional use;

- medical devices, in particular medical those with properties or claims dependent on plant ingredients;

- food supplements and nutraceuticals made of herbal plant substances, in all contexts relevant to their production and marketing;

- cosmetic products, in particular with regard to the use of plant ingredients and their claims.

The student should also be able to acceed and use official databases and be aware about alert and intervention systems for safe use of mediciens and supplements.

Work Placement(s)

No

Syllabus

l. Perception of the social context and the benefit/risk balance associated with the use of medicines and food supplements. Fundamental legal principles: protection, prevention and precaution, participation.

2. Regulatory framework for herbal medicines and other health products (medical devices).

2.1. Specifics of the simplified market access regime for herbal medicines, European Union monographs and registrations in the EU List (List Entries)

3- Regulation 2017/745 as it applies to medical devices with plant ingredients.

4- Regulatory framework for food supplements made from plant substances.

4.1. Rapid risk warning systems for dietary supplements.

4.2. Strategic instruments: monitoring and control plans for food supplements

5- Regulatory framework for vegetable raw materials cosmetic ingredients.

6- Pre-requisites and licensing of production establishments.

Assessment Methods

Assessment
Exam: 50.0%
Resolution Problems: 50.0%

Bibliography

Directive 2001/83/EC of the European Parliament and of the Council

Directive 2004/24/EC of the European Parliament and of the Council

Regulation (EU) 2017/745 of the European Parliament and of the Council

Directive 2001/83/EC, of the European Parliament and of the Council

Regulation (EC) No 178/2002 and

Regulation (EC) No 1223/2009

Directive 2002/46/EC of the European Parliament and of the Council

Regulation (EC) 178/2002 of the European Parliament and of the Council

European Parliament and of the Council 2006.

Regulation (EC) 1924/2006 of the European Parliament and of the Council

EFSA Scientific Committee. Scientific Opinion. Guidance on Safety assessment of botanicals and botanical preparations intended for use as ingredients in food supplements. EFSA Journal 2009; 7(9):1249

EFSA Panel on Dietetic Products, Nutrition and Allergies. General scientific guidance for stakeholders on health claim applications. EFSA Journal 2016;14(1):4367

EU monographs on herbal med.. https://wd