Herbal Medicines

Paramedicines should be requalified to OTC Medicinal Products (WEU) or Traditional Herbal Medicines.

1.WEU (Well Established Use)

This type of application may be submitted „if the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the Community for at least ten years, with recognised efficacy and an acceptable level of safety”

The particulars and documents accompanying an application shall be presented in accordance with the Common Technical Document (CTD) (Module1-5) which were agreed in November 2000 within the International Conference on Harmonisation (ICH), as far as possible in an electronic format.

Detailed information is provided in the Decree of the Minister of Health No. 52/2005 (XI. 18.) EüM and its Annex1.

The most important documents to be submitted are as follows:

Module 1:

• cover letter (also in the original, signed paper copy)
• completely filled Application Form (also in the original, signed paper copy), http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/index_en.htm
• and its all relevant annexes, the most important ones of which are as follows:

- proof of payment (Annex 5.1)

- proof of establishment of the applicant in the EEA (Annex 5.3)

- letter of authorisation for communication on behalf of the applicant/MAH (Annex 5.4, also in the original, signed paper copy)

- Curriculum Vitae of the Qualified Person for Pharmacovigilance (Annex 5.5)

- Manufacturing Authorisations and GMP certificates for the finished product manufacturers and batch release sites (Annex 5.6 and 5.9)

- declaration from the Qualified Person of the finished product manufacturers and batch release sites that the active substances are manufactured in compliance with the detailed guidelines on good manufacturing practice (Annex 5.22)

- letter of access to the Active Substance Master File(s) or copy of Ph. Eur. Certificate(s) of Suitability. (Annex 5.10)

- Ph. Eur. Certificate(s) of suitability for TSE (Annex 5.12)

- Copy of Marketing Authorization(s), SmPCs, and PILs if Marketing Authorization(s) were obtained for the product in any countries (Annex 5.15)

o Other parts of Module 1:

- proposed product information -SmPC, Labelling, PIL ( Module 1.3.1)

- mock-ups of the outer packaging ( Module 1.3.2)

- Consultation with Target Patient Groups (readibility test or bridging report ) (Module 1.3.4.)

- Braille declaration (Module 1.3.6.)

- Information about the experts (Module 1.4)

- Specific Requirements for WEU Applications (Module 1.5.1)

- Information relating to Pharmacovigilance (Module 1.8)

Module 2:

• Quality Overall Summary
• Nonclinical Overview (based on literature references or on own non-clinical studies),
• Clinical Overview (based on literature references or clinical studies with the product)

Module 3:

• Chemical, Pharmaceutical and Biological information according to the requirements of the Decree of the Minister of Health No. 52/2005 (XI. 18.) EüM and its Annex1, Part 1, Chapter 3. In case of herbal medicines the requirements included in Part 3. Chapter 4. also apply.

Module 4:

• Detailed scientific bibliography or own data addressing pharmacological, toxicological and other preclinical characteristics (or reference to a community herbal monograph)

Module 5:

• Detailed scientific bibliography or own data addressing clinical characteristics (or reference to a community herbal monograph)

•  Samples of the product and the active substance(es) and Certificates of Analysis

Fee for Requalification: 405.000 HUF.

2. Traditional Herbal Medicinal Products:

a) they have indications exclusively appropriate to traditional herbal medicinal products which, by virtue of their composition and purpose, are intended and designed for use without the supervision of a medical practitioner for diagnostic purposes or for prescription or monitoring of treatment;

b)they are exclusively for administration in accordance with a specified strength and posology;

c)they are an oral, external and/or inhalation preparation;

d)the period of traditional use as laid down in the Decree of the Minister of Health No. 52/2005 (XI. 18.) EüM has elapsed;

e)the data on the traditional use of the medicinal product are sufficient; in particular

the product proves not to be harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of longstanding use and experience.

(the presence in the herbal medicinal product of vitamins or minerals for the safety of which

there is well-documented evidence shall not prevent the product from being eligible for registration as a traditional herbal medicine, provided that the action of the vitamins or minerals is ancillary to that of the herbal active ingredients regarding the specified claimed indication(s).

The particulars and documents accompanying an application shall be presented in accordance with the Common Technical Document (CTD) (Module1-5) which were agreed in November 2000 within the International Conference on Harmonisation (ICH), as far as possible in electronic format. Detailed information can be found in the Decree of the Minister of Health No. 52/2005 (XI. 18.) EüM and its Annex1.

The most important documents to be be submitted are as follows:

Module 1:

• cover letter (in originally signed paper format too)
• completely filled Application Form (1 originally signed paper copy too), http://ec.europa.eu/enterprise/sectors/pharmaceuticals/documents/eudralex/index_en.htm
• and its all relevant annexes, the most important ones of which are as follows:

- proof of payment (Annex 5.1)

- proof of establishment of the applicant int he EEA (Annex 5.3)

- letter of authorisation for communication on behalf of the applicant/MAH (Annex 5.4, in originally signed paper format too)

- Curriculum Vitae of the Qualified Person for Pharmacovigilance (Annex 5.5)

- Manufacturing Authorisation and GMP certificate for all the finished product manufacturers and batch release sites (Annex 5.6 és 5.9)

- declaration from the Qualified Person of the finish product manufacturers and batch release sites that the active substances are manufactured in compliance with the detailed guidelines on good manufacturing practice (Annex 5.22)

- letter of access to Active Substance Master File(s) or copy of Ph. Eur. Certificate(s) of Suitability. (Annex 5.10)

- Ph. Eur. Certificate(s) of suitability for TSE (Annex 5.12)

- Copy of Marketing Authorization(s), SmPCs, and PILs if Marketing Authorization(s) were obtained for the product in any countries (Annex 5.15)

o Other parts of Module 1:

- proposed product informations-SmPC, Labelling, PIL ( Module 1.3.1)

- mock-ups of the outer packaging ( Module 1.3.2)

- Consultation with Target Patient Groups (readibility test or bridging report ) (Module 1.3.4.)

- Braille declaration (Module 1.3.6.)

- Information about the experts (Module 1.4)

- justification of the legal basis of the application (Module 1.5.1)

Module 2:

• Quality Overall Summary
• Nonclinical Overview, which may be a reference to a community herbal monograph if it is fully applicable)
• Clinical Overview, which may be a reference to a community herbal monograph if it is fully applicable)

Module 3:

• Chemical, Pharmaceutical and Biological information according to the requirements of the Decree *of the Minister of Health* No. 52/2005 (XI. 18.) EüM and its Annex1, Part 1, Chapter 3. supplemented with the requirements detailed in Part 3., Chapter 4.

Module 4:

• Detailed scientific bibliography or own data addressing pharmacological, toxicological and other preclinical characteristics (or reference to a community herbal monograph if it is fully applicable)

Module 5 :

• bibliographical or expert evidence of the fact that the medicinal product in question, or a corresponding product has been in medicinal use throughout a period of at least 30 years preceding the date of the application, including at least 15 years within the Community.
• Demonstration of the fact that the product is not harmful in the specified conditions of use and the pharmacological effects or efficacy of the medicinal product are plausible on the basis of longstanding use and experience.

(Community monographs can be accepted in case the product fully complies with the monograph)

• Samples of the product and the active substance(es) and Certificates of Analysis

Fee for Requalification: 405.000 HUF