Module 2 :

M2 EU and National legislative framework

ITEM

CONTENT

Aims and  Overarching Objectives of the module

This module is aimed to give an overview of the legislative framework regulating the marketing of food supplements and medical devices both at European and national level.

Aims:

·         Acquire a deep knowledge of the legislation regulating the placing on the market of food supplement and medical devices in Europe

·         Knowledge of the legislation at local level

·         Specific legislation for food supplements

·         Specific legislation for medical devices

Overarching objectives:

-       Learning the specific legislation for the marketing of food supplements;

-       Learning the specific legislation for the marketing of medical devices

-       No regulations and /or directives at EU level.

-       The marketing of these products is regulated at national level;

-       A specific module should be dedicated to food supplements

-       Acquiring basic knowledge of anatomy, physiology and nutrition.

-       The economic impact in each country – how it affects local regulations.

Summary of the module content and table of content items

This introductory module gives an overview of the legislative framework regulating the marketing of food supplements and medical devices both at European and national level. It is aimed at acquiring a sounded knowledge of the legislation regulating the placing on the market of food supplement and medical devices in Europe and at local level.

TABLE OF CONTENT

1. EU legislative framework towards the rights of patients
2. Applicable EU legislation for food supplements
3. Medical Devices Regulatory framework
4. Implementing Measures
5. Romanian legislation
6. Bulgarian legislation
7. Turkish legislation 
8. Austrian legislation

Training workload

1.      Theoretical part (hours): 20 hours

2.      Practical part (hours): 10 hours

3.      Assessment (hours): 1 hour

Previous knowledge required

1.      Good communication skills.

2.      Negotiation skills.

3.      Basic ICT skills.

4.      Ability to cooperate with others.

5.      Positive attitudes and ability to express empathy towards people with disabilities.

6.      Basic knowledge in the field of customers services in particular.

7.      Basic knowledge in trading.

8.      Basic information about goods.

9.      Basic knowledge in anatomy and physiology

Educational resources required

1.      Beamer

2.      Laptop

Learning pathways

1.      Face to face: 10 hours

2.      E-learning: 20 hours

3.      Practice:  0 hours

4.      Internship: 1 hour

Learning outcomes upon successful completion of the module

The individual achieves a deep understanding of the regulations for food supplements and medical devices marketing in Europe and especially in each country.

They also achieve a basic knowledge of the main medical subjects in order to be able to provide specific and sounded information when selling specific products. 

Knowledge

1. European legislation for food supplements.

2.  National legislation, in each country, for trading with food supplements.

3. European legislation for trading with medical devices.

4. National legislation, in each country, for trading with medical devices.

Skills

1. Applies legislation about the market of food supplements and medical devices in Europa and on national level.

2. Compares food supplements by composition, purpose and use.

3. Offers medical devices to clients in accordance with the instructions from the competent bodies.

Competencies

1. Strictly applies in his work the regulation for trading with food supplements and medical devices.

ECVET/ECTS points

ECVET points = 5; ECTS points = 1 credit

Assessment (type)

No assessment for this module