Macau RMC 2008

President of the ECCTCM; Vice-president of the European Foundation of TCM;

Vice-president of PEFOTS; Chairman of the Supervision Board of

World Federation of Chinese Medicine Societies; Member of the Expert Committee on the “International

TCM Program for Cooperation in Science and Technology” (Ministry of Science and Technology of

P.R.China).

Dr. Ramón Mª Calduch Lawyer, economist,

Master in European Community Law, Master in Medicine Anthropology,

Doctor h.c. in Business Management

“DIFFERENT LEGISLATION RULES FOR HERBAL PRODUCTS WITHIN THE

EUROPEAN UNION”

Legal situation of Herbal Products in the European Union before 2004

“DIFFERENT LEGISLATION RULES FOR HERBAL PRODUCTS WITHIN THE EUROPEAN UNION”

Restrictive countries Permissive countries

SpainItaly

France

Latin tradition countries

United KingdomHolland

Germany

Anglo-saxon countries

The Traditional Use Registration according to the Herbal Directive will not apply where national regulatory

authorities judge that a herbal medicinal product satisfies the requirements for obtaining a marketing authorisation

under the amended Directive 2001/83/EC

Directive 2004/24/EC (Herbal Directive)

Companies may need the guidance of the Committee on Herbal Medicinal Products


Available for products:

• with an indication “exclusively appropriate” to a traditional herbal medicinal product

• with indications on strength and posology

• oral, external or inhalation preparations

• satisfying the period for traditional use

• with adequate data to support the traditional use

Traditional Use Registration


Traditional use or safety will not need to be demonstrated for products on this list.

Traditional use or safety will not need to be demonstrated for products on this list.

The Committee for Herbal Medicinal Products(HMPC) and the European Commission willestablish a positive list of herbal substances,preparations and combinations to be used in

Traditional Herbal Medicines.


Positive list of products

Labelling Amended Directive 2001/83/EC

Quality Good Manufacturing Practice (GMP) Manufacturer’s licence

Other requirements for Traditional Use Registration


Industrially produced herbal medicines

Standard medicinal product marketing authorization

Traditional Use Registration

Traditional Use Registration Scheme


Problems after the Herbal Directive

The Committe for Herbal Medicinal Products (HMPC) is slow to produce monographs.

Six of the member states have not implemented the Directive yet.

Some member states and the HMPC request for extra testing.


Directive 2004/27/EC

Responsibilities of the Co-ordination Group for Mutual Recognition and Decentralised Procedures (Human):

Aim for consensus between Member States on the grounds of “potential serious risk to public health”

Yearly provide a list of medicinal products that require a harmonized summary of the product characteristics to promote

the harmonization of marketing authorizations


Recognition by Reference Member State

Principle of recognition by Reference Member State (RMS)

Mutual Recognition Mutual Recognition

ProcedureProcedure

Descentralised Descentralised

ProcedureProcedure

RMS has already issued amarketing authorization

Allows to obtain a marketing authorization

in several Member States:RMS required


For those of you who wish to access to the European Union market I will say, as a recommendation, from the legal perspective, choose a country in the EU where to register its products, and afterwards use the Mutual Recognition Procedure for its registration in the other countries. The chosen country has to be in the Anglo-Saxon area and, in my opinion, the most convenient is Holland.

CONCLUSION:CONCLUSION:


THANK YOU FOR YOUR [email protected]

www.mtc.es

Macau RMC 2008

Health & Medicine

Transcript of Macau RMC 2008