EU Traditional Herbal Medicine Registration


I、Project introduction

1. Traditional herbal medicine registration

The simple registration of traditional European herbal medicines is based on the “Original Registration Application for Traditional Herbal Medicines” issued by the European Parliament and the Council of the European Union on March 31, 2004, ie 2004/24/EC, whose core lies in the traditional herbal medicines that meet certain conditions. The European Union's application for listing can reduce animal testing and clinical trials.

Before the 2004/24/EC Directive came into effect, some countries in the European Union allowed Chinese herbal medicines to enter the market in the form of food supplements. Member states must implement the directive by October 30, 2005, and any member state will no longer allow herbal medicines to be used as food. The form is applied for registration in accordance with food regulations. Herbal medicines that have been sold in food form can continue to be sold for another 7 years (ie until April 30, 2011). If the product has a 30-year history of use, including a 15-year history of use in the European Union, it can be carried out on 2004/24/ The traditional herbal medicines of the EC Directive simplify registration, otherwise they should be registered in strict accordance with the drug marketing license or withdrawn from the market in accordance with the provisions of Directive 2001/83/EC.

The approval for the listing of European traditional herbal medicines is valid for 5 years. If you want to continue, you should apply for re-registration by the applicant 3 months before the expiration of the validity period.

2. the scope of application

The simple registration of traditional European herbs is only applicable to herbal medicines with long-term clinical application.

3. Applicant qualification

Applicants and registered holders must be entities within the EU.

Domestic manufacturers can find a body that meets the above conditions within the EU or establish a subsidiary in the EU to be responsible for the submission of applications and sales in the EU.

4. Eligibility for the registration of drugs

Simplified registration of traditional herbal medicines applies to products that meet the following criteria:

(1) The products to be registered must be herbal medicines. The active ingredients can only be herbal substances, herbal preparations or combinations thereof. Some mineral medicines and animal medicines in traditional Chinese medicines are generally not allowed to apply for simplified registration procedures.

(2) There should be unique indications. These traditional herbal medicines are designed to be used for diagnosis, prescription and treatment according to the indications in terms of composition and use.

(3) There must be specific methods, dosages and specifications, and must be oral, topical or inhaled.

(4) There should be literature or expert evidence proving that there is a 30-year history of use, including a 15-year history of use in the European Union.

(5) There are sufficient traditional application data of drugs, especially based on long-term use and experience, it has been proved that the product is harmless under certain conditions, and its pharmacological effect or efficacy is reasonable.

5. Currently approved products

The following are herbal medicines that have been approved in accordance with the European Traditional Herbal Medicine Simplified Registration Procedure:

Devil’s Claw: Harpagophytum procumbens (African Uncaria products)

Feverfew: Tanacetum parthenium (小白菊产品)

Arnica: Arnica montana

Black Cohosh: Cimicifuga racemosa (black cohosh product)

Ⅱ、the service content

1. Provide pre-technical and regulatory support to ensure that customers are properly prepared for the materials required to declare the materials;

2. Instruct the customer to prepare the necessary materials for each module;

3. Review the documents provided by the client and propose amendments to ensure that the quality of the documents meets the requirements;

4. Translate and write a full set of application materials;

5. Provide technical support for on-site inspection.

Conley's service features

1. Provide feasibility assessment to customers before signing the contract, and effectively avoid failures caused by regulations and policy reasons;

2. Provide registration risk and budget assessment, estimate risk, technical difficulty, etc.;

3. After signing the contract, guide the customer to prepare materials one by one, and greatly improve the efficiency.

Ⅲ、the service program

(1) European official registration procedure

EU traditional herbal registration can choose any of the following three procedures:

1. The centralized procedure is submitted to the EMEA and all EU member states are valid after approval.

See the illustration:

 

2.the member state approval process, that is, the drug review department of the EU member states is responsible for the process of drug approval. After approval by the member states, they can also obtain marketing approvals in other EU member states through mutual recognition procedures.

See the illustration:

 

3.Mutual recognition procedures, that is, in addition to applying to an EU member state, and also to submit mutual recognition applications to one or more other EU member states. With the approval of the first member state, other member states should also approve the sale of the drug in the country.

See the illustration:

 

(2) General pre-registration preparation procedures

Pre-investigate pre-registered products, evaluate the possibility, difficulty and risk of a simple registration of traditional European herbs, then guide/assisted customers to collect and prepare the required materials, make up relevant tests, and guide customers to do a good job in European GMP on-site assessment. Prepare, translate and write the required application materials.

See the illustration:

 

Ⅳ、common problems

1. Does the simple registration of European herbal medicines mean that Chinese medicines that are imported into Europe in the future must be registered as medicines and cannot continue to be sold as foods?

2. Does the simple registration of European herbal medicine mean “free of pharmacology and toxicology and clinical”?

3. Is herbal medicine and Chinese medicine the same thing?

4. Will the success of the European herbal medicine abbreviated registration be beneficial to register the product in the United States?

5. Can the European herbal medicine simply register to accept the Chinese medicine of Dafu?

6. What is the relationship between the simple registration of European herbal medicines and the herbs contained in the European Pharmacopoeia?

7. Can our products be registered as a simple European herbal medicine?

8. How much does it cost to register a European herbal medicine? how long?

9. After the European herbal medicine registration is completed, can the product be sold freely in all European countries?

10. Can a confidential formula and patent formula be applied for a brief registration of European herbal medicines?

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