Registration and renewal of the credential certificate for registration

Transcription

1 Registration and renewal of the credential certificate for registration 1. Qualification of the applicant: 1.1 Must be a holder of the license to manufacture or import the psychotropic substances of category 3 or Obtains a manufacturing site that carries GMP certificate indicating the ability to manufacture such product in accordance with the GMP rules. 2. Registration of the general psychotropic products 2.1 The applicant submits two copies of the following documents: The completed Form ว.จ The labels of all package sizes The patient information leaflets in Thai and, if available, English A copy of license to manufacture or import the psychotropic substance, and a copy of the Good Manufacturing Practice (GMP) certificate If the sell representative is available, a copy of license to sell the psychotropic substance of category 3 or 4 must also be submitted. 2.2 Upon granting a permit to manufacture or import the samples of the psychotropic substances the Narcotics Control Division shall issue the permit form (form ว.จ.2) and return one copy of the application dossier to the applicant to be used as a prove of legitimate manufacturer or importer of the psychotropic substances. 2.3 The applicant submits three copies of the completed application form (Form ท.จ.1) for registration and the following documents: A letter stating that the applicant accepts the conditions of the application for registration of the psychotropic (Form ท.จ.1) A completed Form ท.จ.3, for the renewal of the credential certificate for registration of medicinal product of the psychotropic substance.

2 2.3.3 The credential certificate for registration, Form ท.จ.2, (for renewal case) Variation of the formulation: ( ) same as the original formulation, ( ) different from the original formulation and a table of comparison of the two formulations must be attached A copy of the license to manufacture or import psychotropic substance of category 3 or 4. - For the first time application, a copy of the license to manufacture or import the drug sample of the psychotropic substance, Form ว.จ.2 is required. - Drug sample of the psychotropic substance A copy of license to sell the psychotropic substances of category 3 or 4 of the representative of the direct sell is available Certificate of Pharmaceutical Product or Certificate of Free Sale is required for the import The Good Manufacturing Practice (GMP) certificate of the oversea manufacturer Photograph of the Drafts of the labels and patient information leaflets The formulation of one unit The complete batch manufacturing master formula Method of manufacture In-process specification and the control method Raw material specification and the control method Certificate of analysis of the raw material of the active ingredient Analytical data and the chromatogram or spectrum of the raw material of the active ingredient Finished product specification and the control method Certificate of analysis of the finished Analytical data and the chromatogram or spectrum of the finished Packaging, labeling and storage Method validation, in the case that the analysis methods used does not conform to the one(s) in the official pharmacopoeias.

3 Data from the stability study A letter of authorization. 2.4 Manufacturing of the generic products of which the standard procedure of dissolution test is specified, comparison data of the dissolution/release profile of the generic drugs and the prototype must be presented. In the event that the prototype is not available, data of the dissolution/release profile of three batches of the generic drugs must be provided instead. 2.5 The applicant shall be notified of any incomplete or incorrect of the documents. After the applicant provides the remedy of such documents, the application number shall then be issued. 2.6 Review of the application dossier will be done by the expert(s) and the applicant shall be notified of the results of the review. The applicant must fulfill any correction or additional documents required according to the review experts within the time stated. 2.7 After the application dossier has been approved by the experts, the Food and Drug Administration will notify the applicant the tests and the test/analysis items needed to be performed on the psychotropic product by the FDA as well as the amount of the sample(s) of the psychotropic products and reference standard substances required for the tests. The applicant shall also be notified of the time those samples and reference standard substances are to be submitted for the tests. 2.8 if analyses results to be as standard indicated in finished Products, specifications in psychotropic products. Narcotics Control Division will inform companies to provide the labels and the patient information leaflets of Psychotropic Substances in order to submit to the meetings of Sub-Committee considering Psychotropic products and Psychotropic Substances Committee considering the approval of Psychotropic Products Registrations 2.9 The credential certificate for registration of the psychotropic products (for m ท.จ.3) shall be issued only if the labels and patient information leaflets of the psychotropic substances has been produced in accordance with what specified in the registration.

4 2.10 The credential certificate is valid for 5 years from the date of issuance. Renewal of the credential certificate must be done no less than 12 months prior to its expiration date. 3. Renewal of the credential certificate for registration of psychotropic 3.1 The license holder wishes to renew the credential certificate must submit the application no less than 12 months prior to the expiration date of the credential certificate. 3.2 The applicant submits three copies of the completed application form for registration (Form ท.จ.1) and the following documents: The license holder must notify the Narcotics Control Division of any variation from what stated in the registered psychotropic product i.e. the manufacturing formula, the analysis methods, the methods of quality control etc A table of comparison of the previous and present formula of the A copy of license to manufacture or import the psychotropic substances of category 3 or If sell representative is available, a copy of license to sell the psychotropic substances of category 3 or 4 must also be submitted GMP certificate Certificate of Pharmaceutical Product or Certificate of Free Sale is required for the import Samples of the psychotropic Photographs of the pharmaceutical product(s) The labels The patient information leaflet(s) for the psychotropic substances The formula.

5 The complete batch manufacturing master formula Method of manufacture Raw material specification and the control method In-process specification and the control method Finished product specification and the control method Labeling Analytical data and the chromatogram or spectrum of the active ingredient Certificate of analysis of the active ingredient (raw material) Analytical data and the chromatogram or spectrum of the finished Certificate of analysis of the finished Method validation, in the case that analysis methods used does not conform to the one(s) in the official pharmacopoeias The package that is in the same form of the one intended to present into the market and used in the stability study Data of the stability study of the finished product Storage condition (the same as the one used in the stability study) A letter of authorization 3.3 In the event that the comparison data of the dissolution/release profile of the generic drug and the prototype has never been submitted and the prototype is not available in the market the applicant must prepared data of the dissolution/release profile of 3 batches of such generic 3.4 The applicant shall be notified of any incomplete or incorrect of the documents. After the applicant provides the remedy of such documents, the application number(s) shall then be issued. 3.5 Review of the application dossier will be done by the expert(s) and the applicant shall be notified of the results of the review. The applicant

6 must fulfill any correction or additional documents required according to the review experts within the time stated. 3.6 After the application dossier has been approved by the experts, the Food and Drug Administration will notify the applicant the tests and the test/analysis items needed to be performed on the psychotropic product by the FDA as well as the amount of the sample(s) of the psychotropic products and reference standard substances required for the tests. The applicant shall also be notified of the time those samples and reference standard substances are to be submitted for the tests. 3.7 Relevant authorities shall file for permission to issue the registration number should the drug sample(s) pass the quality tests and meet the standard qualification as specified in the Finished Product Specification and the committee of the psychotropic substances has authorized the renewal of the credential certificate for registration of the psychotropic products. 3.8 The credential certificate for registration of the psychotropic products (Form ท.จ.3) shall be issued only if the labels and patient information leaflets of the psychotropic substances has been produced in accordance with what specified in the registration. 3.9 The credential certificate is valid for 5 years from the date of issuance. Application for renewal of the credential certificate must be submitted no less than 12 months prior to its expiration date.