Reclassification of Non-Medicinal Curative Products
If you intend to market your curative products that currently hold a valid registration entry or marketing authorization with therapeutic claims after April 1, 2011, and therefore plan their reclassification into medicinal products, please inform us of your intentions in advance. Should any difficulties arise while compiling the documentation to be submitted for the reclassification procedure, we provide personal consultation opportunities (subject to prior arrangement).
If preparations are not reclassified as pharmaceuticals, they may only be authorized under new (national) procedures after April 1, 2011.
Pursuant to Section 3 of Decree 53/2005 (XI. 18.) EüM on the conditions for reclassifying curative substances or products into medicinal products for human use, the original documentation submitted for registration and its supplements may be utilized as part of the documentation proving quality, relative safety, and efficacy.
1. Well-Established Use (WEU) – Reclassification as Non-Prescription (OTC) Medicinal Products
Such an application may be filed if "the applicant can demonstrate that the active substances of the medicinal product have been in well-established medicinal use within the EEA for at least 10 years, with recognized efficacy and an acceptable level of safety."
Documents and data required for authorization should preferably be submitted in electronic format. Detailed guidance on the dossier requirements is provided in Decree 52/2005 (XI. 18.) EüM and its Annex 1.
Key Components of the Dossier:
- Module 1: Covering letter (including an original signature on paper), signed application form (1 copy on paper), and its annexes:
- Proof of payment (Annex 5.1)
- Proof of applicant's establishment in the EEA (Annex 5.3)
- Letter of authorization/power of attorney, if applicable (Annex 5.4, with original signature)
- Curriculum vitae of the Qualified Person Responsible for Pharmacovigilance (QPPV) (Annex 5.5)
- Manufacturing authorizations and GMP certificates for finished product manufacturing, testing, and batch release sites (Annexes 5.6 and 5.9)
- TSE certificate(s) (Annex 5.12)
- Copies of existing marketing authorizations, Summaries of Product Characteristics (SmPC), and package leaflets (Annex 5.15)
- Draft product information texts (Module 1.3.1)
- Draft packaging mock-ups (Module 1.3.2)
- Readability testing of the package leaflet or request for exemption/bridging (Module 1.3.4)
- Braille statement (Module 1.3.6)
- Experts' curriculum vitae and signatures (Module 1.4)
- Specific requirements for WEU applications (Module 1.5.1)
- Pharmacovigilance system summary (Module 1.8)
- Module 2: Quality Overall Summary; non-clinical overview and summary; clinical overview and summary (based on literature citations or proprietary studies)
- Module 3: Detailed chemical, pharmaceutical, and biological documentation according to Part 1, Chapter 3 of Annex 1 to Decree 52/2005 EüM
- Module 4: Non-clinical pharmacological, toxicological, and safety documentation from literature or proprietary testing (or reference to EU monographs)
- Module 5: Clinical study reports or published clinical literature data (or reference to EU monographs)
- Other: Evaluation samples (finished product and active substance) and analytical certificates
2. Reclassification as Traditional Herbal Medicinal Products (THMP)
Traditional herbal medicinal products are preparations that:
- have indications exclusively appropriate to traditional herbal medicinal products intended for use without the supervision of a medical practitioner;
- are exclusively administered in accordance with a specified strength and posology;
- are oral, external, or inhalation preparations;
- have satisfied the period of traditional use specified in Decree 52/2005 (XI. 18.) EüM;
- have sufficient data on their traditional use—in particular, demonstrating that the product is not harmful under normal conditions of use and its pharmacological effects or efficacy are plausible on the basis of long-standing use and experience.
The presence of vitamins or minerals in the herbal medicinal product does not prevent the granting of a traditional herbal registration, provided that safety is adequately substantiated.
Key Components of the Dossier:
- Module 1: Covering letter, application form, and annexes (analogous to the WEU application)
- Module 2: Quality overall summary; non-clinical and clinical overviews (may be substituted by reference to an EU herbal monograph)
- Module 3: Detailed chemical, pharmaceutical, and biological information, supplemented by the requirements described in Part 3, Chapter 4
- Module 4: Non-clinical bibliographic data (may be substituted by reference to an EU herbal monograph)
- Module 5: Bibliographical evidence demonstrating that the medicinal product has been in medicinal use for at least 30 years prior to the date of application, of which at least 15 years within the EEA
- Other: Evaluation samples and analytical certificates
Source: National Institute of Pharmacy (OGYI)
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