Decree No. 228 / 2008 Coll.
Ordinance on the Registration of Medicinal Products
Valid
Order
Effective from 01.07.2008
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228
DECLARATION
of 23 June 2008
on the authorisation of medicinal products
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to § 114 (2) and in order to implement § 2 (2) (c), § 8 (5), § 26 (5) (l), § 26 (7), § 27 (5), § 27 (7) and § 12, § 28 (1) (c), § 28 (3), § 29 (2), § 30 (3) and (7), § 32 (3), § 33 (3) (g) (f), § 34 (3) and (3), § 45 (7) (b), § 49 (5), § 91 (2) (b) and § 38, § 40 (2) (f), § 40 (3), § 44 (3) and (9) (f), § 45 (5), § 91 (5), § 91 (2), § 92 (2) (b), § 92 (12), § 92 (12), § 38), § 38 (3), § 40 (3), § 40 (3), § 40 (3), § 40 (3),
Preliminary provisions
(1) This Decree implements the relevant European Union1 provisions and regulates the marketing authorisation of medicinal products, its amendments, extensions, the transfer of marketing authorisation, the issuing of authorisations for the simultaneous importation, submission and design of specific treatment programmes using non-authorised medicinal products for human use, the method of notification and evaluation of the adverse effects of a medicinal product, including the formalities for periodic safety update reports, and the manner and extent of notification of the prescription or use of an unregistered medicinal product, the particulars of the reports given by the person responsible for pharmacovigilance, the submission of information on a non-interventional study in the Czech Republic and its termination, the conditions of storage of the dossier, including the extent, and further lays down rules for determining the extent of information provided from the pharmacovigilance system.
(2) For the purposes of this decree:
(a) vaccines, toxins and sera consisting of human immunological medicinal products as referred to in Article 2 (2) (c) of the Drug Act:
1. vaccines used for active immunisation such as diphtheria, tetanus and cough, polio, hepatitis A viral, hepatitis B viral, cholera, tuberculosis (BCG), varicella,
2. preparations used for passive immunisation such as diphtheric antitoxin, varicella globulin, antilymphocytic globulin,
3. preparations used to verify immunity, in particular tuberculin and tuberculin PPD, toxins for Schick test and Dick test, brucellosis,
(b) any medicinal product for human use that is intended to detect or induce specific changes in the immune response to an allergic agent,
(c) a new active substance, an active substance which is:
1. chemical or biological in nature or is radiopharmaceuticals and is not yet included in any product authorised within the European Communities (hereinafter referred to as the Community),
2. isomer, mixture of isomers, complex, derivative or salt of a chemical having different properties with regard to the safety and efficacy of the chemical contained in a product already authorised within the Community;
3. a biological substance having a different molecular structure, the origin of the source of the raw material or the method of manufacture from a biological substance contained in a preparation already authorised within the Community; or
4. the nature of the radiopharmaceuticals and is a radionuclide or carrier not yet included in any product already authorised within the Community or a mechanism for integrating radionuclide into a molecule which has not yet been used in any product authorised within the Community;
(d) a biological substance which is produced or extracted from a biological source and which requires a combination of physical, chemical and biological tests and data on the production process and its control to characterise and establish the quality;
(e) a biological medicinal product, the active substance of which is the biological substance; As a consequence, biological medicinal products are primarily considered immunological medicinal products, blood derivatives, medicinal products falling within the scope of the Community Regulation governing Community procedures for the registration and supervision of medicinal products2) and advanced therapy products as defined in Part IV of Annex 1 to this Regulation.
Specific treatment programs using unregistered human products in the Czech Republic
(1) The content of the proposal for a specific treatment programme (hereinafter referred to as the "treatment programme") is in addition to the data provided for in the Drug Act.
(a) the firm and its registered office, if it is a legal person, or the name or, where appropriate, the name, surname and place of business, if it is a natural person,
(b) justification for the treatment programme; a justification for the fact that the treatment programme is the subject of treatment, prevention or diagnosis of rare diseases or any other emergency need and is a serious threat to human health; a state of serious human health is considered to be a condition that may cause death, endanger life, require hospitalisation or prolongation of ongoing hospitalisation, may result in permanent or significant harm to health or reduced capacity; other treatment, prevention or diagnosis to be considered in this case,
(c) the name of the human product to be used in the treatment programme, including indication of the content of the active substances, the size and number of packages and whether the human product is authorised abroad; if registered abroad, the country, year of registration, marketing authorisation holder and registration number shall be indicated;
(d) pharmaceutical information on the medicinal product used to the extent appropriate to the marketing authorisation; in the case of medicinal products for human use registered in a Member State of the Community or in a State with which an international agreement has been concluded (3), pharmaceutical data shall not be submitted if the summary of the product characteristics referred to in point (f) is contained in the draft treatment programme; in other cases, pharmaceutical data shall be submitted to the extent appropriate to the application for authorisation or reporting of a clinical trial under another legislation4); or it is possible to replace these data by a proof of quality checks provided for in Section 62 (1) of the Medicines Act,
(e) proof that the manufacturer provides the medicinal product for the treatment programme if the supplier of the medicinal product is not the producer of the medicinal product;
(f) pre-clinical and clinical data on a medicinal product to the extent appropriate to the investigator's information file submitted in the application for authorisation of a clinical trial (4); in the case of medicinal products for human use authorised abroad, this data may be replaced by a summary of the product characteristics corresponding to a text approved by the competent authority of the country where the medicinal product is authorised;
(g) a treatment programme plan defining the target group of persons, indications, restrictions for inclusion in the programme, how to use the human product, including dosing, duration of the treatment programme,
(h) the method of distribution and identification data (5) of the person responsible for the distribution of the medicinal product; such information shall be the business name and registered office of that person, if it is a legal person, or the name or, where appropriate, the name, surname and place of business of that person, if it is a natural person; if the supplier is not a distributor, proof shall be provided that the distributor is informed and agrees to ensure distribution within the treatment programme;
(i) the method of dispensing the human product;
(j) the method of monitoring and evaluating the safety and efficacy of the human product;
(k) information for a patient in the Czech language appropriate to the relevant information to the designated clinical trial subjects and, where appropriate, the package leaflet of the medicinal product;
(l) identification data (5) of persons responsible for monitoring the course of the treatment programme and data on the intervals for carrying out the control and the way in which it is documented;
(m) proof of reimbursement of expenditure for the examination of the application.
If the applicant is not a sponsor of a draft treatment programme of a manufacturer, distributor or marketing authorisation holder of a medicinal product for human use, and if it is a treatment programme for which he is of public interest or which may have particularly significant consequences for a wider range of persons, the Institute shall, at the request of the petitioner, provide synergies in the collection of the data referred to in points (c) and (d) to the extent available to him.
(2) The Institute shall draw up an opinion which shall be forwarded to the Ministry of Health (hereinafter referred to as the Ministry). The Ministry, taking into account this opinion, shall give its written consent to the implementation of the treatment programme or reject the proposal, if appropriate. The outcome of the assessment shall be communicated by the Ministry to the petitioner and the Constitution, which shall, in the event of consent, assign a code to the medicinal product for human use.
(3) The following information shall be published on the treatment programme for which consent has been given:
(a) the name of the medicinal product, its pharmaceutical form, the qualitative and quantitative content of the active substance in the medicinal product, the package size, the manufacturer or, where applicable, the marketing authorisation holder in another country, the distributor or the person importing the medicinal product from third countries;
(b) the name and, where applicable, the name, surname and place of business of the petitioner, if any, if it is a natural person, or the business name and registered office, if it is a legal person;
(c) the objective of the treatment programme, the workplace at which the treatment programme takes place and the duration of the consent.
Data and documentation on applications
(1) Applications and other documentation submitted by the Institute for Human Products or the Veterinary Institute for Veterinary Products shall be submitted in electronic form unless otherwise agreed with the Institute for Human Products or the Veterinary Institute for Veterinary Products in specific cases. In the case of medicinal products for human use, the eCTD or NeeS19 electronic format shall be used for the processing of the application and other documentation in electronic form, as specified by the Institute; This format shall also apply to information and reports submitted under this Decree in electronic form of the Constitution. In the case of veterinary medicinal products, the VNees electronic format shall be used, unless otherwise agreed with the Veterinary Institute in specific cases.
(2) In addition to the information provided for in the Medicines Act, the application shall state:
(a) the business name and registered office of the legal person, or the name or, where applicable, the name, surname and place of business of the natural person, where that person makes an application under the authority of the applicant;
(b) a proposal for the method of dispensing the product, if it is for an application for a marketing authorisation or a change in the marketing authorisation relating to the method of dispensing the product;
(c) the registration number of the product where the application for a modification, extension, transfer or withdrawal of the marketing authorisation is sought.
(3) Where an application is submitted by the person empowered by the applicant, this shall be supported by an authorization signed by the principal.
(4) Applications shall be accompanied by proof of payment of the administrative fee and proof of reimbursement of the expenditure of the examination of the application on the appropriate form, indicating the information enabling the payment to be identified. Where the applicant requests a reduction or remission of reimbursement of expenditure, he shall describe the facts justifying such a procedure.
(5) The completed application form shall be submitted in electronic form in a format specified by the relevant institute in a way enabling remote access. If the package leaflet is also included in the draft information on the packaging, no separate draft package leaflet shall be required. In the case of applications for mutual recognition by Member States under Article 41 of the Medicines Act, Czech proposals for the summary of product characteristics, data on packaging, package leaflet and models of all internal and external packaging in which the product is to be marketed, including colour graphic presentation, shall be submitted no later than 5 days after the conclusion of the procedure under Article 41 (4) of the Medicines Act.
(6) Cases under Section 38 of the Drug Act are considered to be
(a) applications for a marketing authorisation or for a change in the labelling of a product in which the applicant expresses an interest in placing the information on the packaging in a non-Czech language, the product to be supplied by the marketing authorisation decision is subject to medical prescription, provided that:
1. the product is intended for the treatment of serious diseases and for use in the provision of medical care under the supervision of a doctor, including the treatment of a patient and outside a medical facility, if it is for human use;
2. it can be inferred from the frequency of the disease that the number of packages on the market does not exceed 5000 units per year, if it is for human product,
3. the availability of the product in the Czech Republic is significant with regard to the protection of animal health, public health, the protection of the environment or the well-being of animals, if the veterinary product is marketed in quantities not exceeding 1000 packages per year,
4. the applicant shall submit a draft label on the outer packaging in English, German or Slovak; and
5. is not registered or marketed with an equivalent product with a label in the Czech language,
6. an appropriate registration number in the Czech Republic is added to the outer packaging or, if there is no outer packaging, to the outer packaging,
(b) applications to allow the placing on the market of individual batches of the preparation if the particulars on the packaging are in a language other than the Czech language, provided that:
1. is not registered or placed on the market in sufficient quantities for the needs of patients in the Czech Republic or for the provision of veterinary care of an equivalent product with a packaging marked in the Czech language;
2. the number of packages of the product corresponds to the need to resolve the immediate shortage of the product, the label of which is in the Czech language,
3. the inavailability of the product would have immediate serious consequences for public health in the case of a human product, or for a veterinary medicinal product for animal health and well-being, public health or the environment,
4. the lot of the product has been placed on the market in a Community State,
5. the essential information to be considered as the name of the product, strength, pharmaceutical form, active substance, packaging size, storage method and shelf life correspond to the conditions of the authorisation in the Czech Republic and may be derived from the text in a foreign language or supplemented on the packaging in the Czech language, and the registration number in the case of veterinary medicinal products; and
6. the marketing authorisation holder shall ensure that each individual package leaflet is accompanied by an approved package leaflet in the Czech language or, in exceptional cases, if the medicinal product is for human use, the marketing authorisation holder shall otherwise ensure that the patient receives the information contained in the relevant package leaflet.
(7) Compliance with the conditions laid down in paragraph 6 (a) (2) and (3) shall be demonstrated by the registrant or by a change in the balance sheet of the expected annual consumption, by consumption for registered products in previous years. In the event of subsequent consumption of more than 5000 packages per year, if the product is for human use, or 1000 packages per year, if the veterinary medicinal product is for veterinary use, the marketing authorisation holder shall submit an application to amend the marketing authorisation for labelling in the Czech language. Amendments to the marketing authorisation referred to in paragraph 6 shall be considered as changes to the labelling of the product not related to the summary of product characteristics under Section 35 (5) of the Drug Act. Compliance with paragraph 6 (a) (1), (4) and (5) and with paragraph 6 (b) shall be supported by the applicant in the application and its annexes.
(8) The procedures for individual types of applications or notifications drawn up in accordance with the guidelines issued by the Community institutions, including the necessary supporting documents and forms, shall be published by the Institute in a manner which allows remote access and, where appropriate, in the Bulletin of the State Institute for Drug Control and are available in the Institute, if the application and notification concerning medicinal products for human use are concerned. If the application and notification concerning veterinary products are concerned, they shall be treated in a similar manner in accordance with the first sentence and the information shall be published, where appropriate, in the Bulletin of the Institute for State Control of Veterinary Bioprafts and Medicines and available at the Veterinary Institute.
(9) When compiling and submitting registration dossiers, registrants shall take into account the instructions issued by the Institute in accordance with the instructions issued by the Community institutions.
Marketing Authorisation Application
The scope of the data submitted in the application for a marketing authorisation and the accompanying dossier shall be determined according to the specific nature of the application; the applications are:
(a) an application which is supported by documentation in the full scope of the requirements laid down in Article 26 (5) of the Law on Medicines and Annexes 1 to 5 to this Decree (hereinafter referred to as "the individual application"); This type of application also includes applications for registration of another pharmaceutical form, additional strengths or other routes of administration of the product already authorised on the basis of a separate application; a separate application is also made for a marketing authorisation based on the well-established therapeutic use of active substances in a product contained in accordance with Section 27 (7) of the Medicines Act ("the literary application ') and an application for a marketing authorisation with the consent of the marketing authorisation holder using pharmaceutical, preclinical and clinical data of the already authorised product under Section 27 (9) of the Medicines Act (" the application with the consent of the holder'),
(b) an application for authorisation of a product containing active substances which are components of authorised products but which have not yet been used in combination in the Community for therapeutic purposes, in accordance with Section 27 (8) (hereinafter referred to as the "fixed combination application"),
(c) the application, by reference to the results of the pharmacological and toxicological tests, the results of the clinical trials and, in the case of the veterinary medicinal product, the residue safety tests already submitted by another marketing authorisation holder in the context of another marketing authorisation procedure
1. in accordance with Article 27 (1) of the Law on Medicines, provided that it is generic under Article 25 (4) (b) of the Law on Medicines, or
2. in accordance with Section 27 (4) of the Medicines Act, if the product does not comply with the definition of generic in accordance with Section 25 (4) (b) of the Medicines Act or if bioequivalence cannot be demonstrated by studies of bioavailability or in the event of changes in the active substance or active substances, therapeutic indications, strengths, pharmaceutical forms or routes of administration compared to the reference medicinal product; or
3. in accordance with Article 27 (5) of the Drug Act, provided that it is a similar biological product; in the case of such a request, the period of 8 years or 6 years, as the case may be, pursuant to Article 27 (1) of the Law on Medicines and, where applicable, the 13 years provided for in Article 27 (1) of the Law on Medicines must expire at the latest by the date of the application,
(d) a request for a simplified procedure for the registration of a homeopathic medicinal product in which no evidence of therapeutic efficacy is required (hereinafter referred to as "the application for a simplified registration of a homeopathic product") under Section 28 or 29 of the Drug Act; This application may be submitted only for products for which a sufficient degree of dilution ensures the safety of the product; the product must not contain more than 1 part of the mother tincture in 10,000 parts or, if applicable, more than one hundredth of the lowest dose used in alopecia with regard to active substances whose presence in the alopecia results in the need for a prescription; the homeopathic preparation may contain several components,
(e) an application for registration of a traditional herbal medicinal product under Section 30 of the Drug Act;
(f) an application for registration of a specific medicinal product for human use under Section 28a of the Drug Act.
Documentation submitted with application for registration of medicinal products for human use
(1) The content and breakdown of the data and documentation submitted with the application for authorisation of a medicinal product for human use are set out in Annexes 1, 3 to 5 to this Decree. The scope of the dossier submitted with the application corresponds to the knowledge of the human product, its nature, the therapeutic benefits it brings and the risks associated with its use.
(2) The application for authorisation of a medicinal product for human use shall contain all information concerning the evaluation of the medicinal product for human use, whether favourable or unfavourable to the medicinal product for human use. In particular, all relevant details of any incomplete or interrupted pharmacological-toxicological test or clinical trial concerning the human product, as well as of the completed clinical trial, relating to treatment indications not included in the application, must be provided. Comparative studies shall also be submitted with other medicinal products or other treatments and non-intervention studies, if available.
(3) All monographs, including general monographs and general statuses of the European Pharmacopoeia under Section 11 (c) of the Drug Act, are applicable if part of the documentation is of quality (chemical, pharmaceutical and biological information). A certificate of conformity with the European Pharmacopoeia issued by the European Medicines Quality Directorate, which replaces the parts of the dossier set out in that Annex, may be presented under the conditions laid down in Annex 1 to this Decree.
(4) A separate application shall be supported by the full documentation set out in Annex No 1 to this Order. In the case of a literary application, the rules set out in Annex 1 to this Decree, Part II, point 1, shall apply when attaching a well-established therapeutic use. The application shall be accompanied by the relevant technical literature. In the case of a request with the consent of the holder, such consent shall be supported by a declaration of signature. The holder shall have permanent access to or hold the documentation. The informed consent applies to all modules, so it is only possible for the same human product.
(5) For applications referred to in Section 4 (c), the data referred to in Annex 1 to this Decree, modules 1, 2 and 3 and the relevant parts of other modules, showing and justifying the non-submission of the results of pre-clinical trials and clinical trials, shall be submitted. In addition, appropriate documentation shall be provided to assess those safety and efficacy aspects of the medicinal product not included in the dossier referred to; the similarity of the human product for which registration is sought, in relation to the human product referred to, for example, by a proof of bioequivalence or pharmacodynamic or therapeutic equivalence should be demonstrated. In the case of applications under Section 4 (c), the proposed summary of product characteristics shall correspond to the current summary of product characteristics referred to. Both the final version of the draft SPC and the text with highlighted changes to the current SPC referred to shall be presented in both written and electronic form. Any deviation of the proposed SPC from the current SPC shall be justified including indications or pharmaceutical form that will be protected by patent law at the time of placing the generic on the market.
(6) In the case of similar biological medicinal products which do not meet the conditions for the definition of generic under Section 25 (4) (b) of the Drug Act, for example because of differences in raw materials or differences in the production processes of such a biological medicinal product and of the reference biological medicinal product, the results of relevant pre-clinical trials or clinical trials relating to these conditions must be submitted. The type and quantity of additional data to be submitted shall comply with the relevant criteria laid down by other legislation4) and the relevant European Commission guidelines ("the Commission '), the European Medicines Agency (" the Agency') and specifying the guidelines of the Constitution. Where an appropriate reference product is registered in the Czech Republic, reference may not be made to a product registered in another Member State. The European reference product shall only be used if the appropriate reference product is not or has not been authorised in the Czech Republic. Information shall be provided on the country of origin of the European reference product and on the countries in which it is applied.
(7) The application for a simplified authorisation of a medicinal product for human use shall not be submitted with the Summary of Product Characteristics, the clinical summary and the clinical summary from Module 2 and Module 5 of Part I of Annex 1 to this Regulation. Module 5 is replaced by documentation justifying the homeopathic use of the basic substance or basic substances on the basis of relevant bibliographic evidence. With regard to modules 3 and 4, the data referred to in point 3 of Part III of Annex No 1 to this Regulation shall be submitted.
(8) The application for registration of a traditional herbal medicinal product shall be submitted in accordance with Annex 1 to this Regulation. The proposal for a summary of product characteristics as set out in Annex 3 to this Regulation for a traditional herbal medicinal product does not contain point 5 - Pharmacotherapeutic properties.
(9) The application for registration of a specific human homeopathic medicinal product authorised under Section 28a of the Drug Act shall be submitted in accordance with Annex 1 to this Decree. In Module 3 of Part I of Annex No 1 to this Order, the data referred to in Part III, point 3 of Annex No 1 to this Regulation shall be submitted.
(1) The reserved medicinal products for human use are:
(a) medicinal teas and medicinal teas;
(b) adsorption anti-diarrhoeic agents containing activated charcoal if each pack of human product contains not more than 20 units of pharmaceutical form,
(c) antiemetics containing teklan moxastinia at a maximum of 25 milligrams per unit of formulation, and if each pack of human product contains a maximum of 20 units of formulation,
(d) human products containing paracetamol as a maximum of 500 milligrams per unit of pharmaceutical form, and if each pack of human product contains a maximum of 12 units of pharmaceutical form,
(e) human products containing ibuprofen as a maximum of 200 milligrams per unit of pharmaceutical form, and if each pack of human product contains a maximum of 20 units of pharmaceutical form,
(f) human products intended for surface disinfection of minor skin injuries and disinfectant human products intended for external use;
(g) medicinal products for smoking, containing nicotine,
(h) human products containing exclusively the active substance or active substances of the pharmacotherapy group antacid,
(i) human medicinal products containing the active substance pantoprazole as a maximum of 20 mg per unit of pharmaceutical form and, if one pack of human product contains not more than 14 units of pharmaceutical form, in an indication of short-term treatment of reflux symptoms in adults,
(j) human medicines to relieve pruritus containing the active substance dimetindene for topical administration,
(k) human products containing the active substance difenhydramine for topical application,
(l) medicinal products for human use containing the active substance aciclovir for topical application, as indicated for topical treatment of fowls of the lips and face,
(m) human products containing the active substance diclofenac for topical application,
(n) medicinal products containing the active substance azelastine for topical application in the indication allergic rhinitis and conjunctivitis,
(o) medicinal products for human use covered by the medicinal product group antihistamines for systemic use containing the active substance cetirizine at a maximum of 10 mg per unit of pharmaceutical form, and if each pack of human product contains a maximum of 30 units of pharmaceutical form,
(p) medicinal products for human use included in the medicinal product group antihistamines for systemic use containing the active substance levocetirizine at a maximum level of 5 mg per unit of pharmaceutical form and if each pack of human product contains a maximum of 21 units of pharmaceutical form.
(2) In assessing the interchangeability of the names referred to in Article 31 (5) (a) (4) of the Medicines Act, account shall be taken, in particular, of whether the name in paper, manuscript or pronounced form is not interchangeable with the name of another human product. The assessment shall take into account the likelihood of confusion in the normal treatment of the medicinal product and the consequences of possible confusion on patients' health.
(3) In addition to the documentation referred to in paragraph 4 or 5, the documentation set out in Annex 6 to this Decree shall be submitted if a release of a medicinal product for human use is proposed in the application without a prescription or without a prescription with a restriction or, where appropriate, classification among reserved human products.
(4) The conclusions of the examination of the legibility and clarity of the package leaflet pursuant to Article 26 (5) (n) of the Medicines Act are to be submitted in the case of a medicinal product for human use with an application for a marketing authorisation and an application for a change to the marketing authorisation which results in a significant change in the package leaflet. The package leaflet is understood if patients are able to find, understand and follow the information necessary for the correct and safe use of the human product in the package leaflet. The applicant may make use of a previously submitted assessment of the legibility and clarity of the package leaflet in the context of the assessment of other medicinal products for which he was an applicant, either similar to the product concerned or relating to the same safety issue. In such a case, a statement of reasons must be provided with the application. The reference cannot be used and an assessment of the legibility and clarity of the package leaflet should be made, for example, for human products containing a new active substance, for changing the mode of delivery, in case of a significantly different new variant of the human product, in the case of a new target group of patients, where it is necessary to highlight certain instructions for the use of the human product. Where an application is submitted in several Member States, it is sufficient to carry out an assessment of the legibility and clarity of the package leaflet in one of the official languages of the Member States.
(5) With the application for a marketing authorisation, or before the marketing authorisation is granted, models of all internal and external packaging in which the medicinal product is to be placed on the market shall be submitted, including colour graphic presentation and one sample of the human product from each type of immediate packaging. The Institute may waive the requirement to submit a sample.
Documentation submitted with application for registration of veterinary products
(1) Data and documentation shall be submitted with the application for registration of the veterinary medicinal product, the content and the breakdown of which are set out in Annexes 2 to 5 to this Decree. These Annexes shall also apply to the submission of data and documentation for the purposes of mutual recognition of registrations under Section 41 (1) of the Act. The scope of the dossier submitted with the application corresponds to the knowledge of the veterinary medicinal product, its nature, the therapeutic benefits it brings and the risks associated with its use and the current level of scientific knowledge and technical progress in the field of veterinary medicine.
(2) The application shall contain all information concerning the evaluation of the veterinary medicinal product concerned, whether favourable or unfavourable to the veterinary medicinal product. In particular, all relevant details of any incomplete or interrupted test or evaluation concerning the veterinary medicinal product shall always be provided.
(3) A separate application is supported by a complete dossier as set out in Annex 2 to this Decree. In the case of a literary application, the requirements set out in Annex 2 to this Decree shall apply mutatis mutandis to applications supported by experimental data.
(4) For applications using a reference, the reports prepared by experts in accordance with Title VI of Annex 2 to this Regulation shall not be submitted for parts of the dossier for which reference is made to the results of pharmacological and toxicological tests, the residue safety tests and the results of clinical trials already submitted in the context of another marketing authorisation procedure by another marketing authorisation holder. Where appropriate, the documentation necessary for the assessment of the safety and efficacy issues of the veterinary medicinal product which are not included in the dossier referred to shall be submitted for the applications referred to in Article 4 (c); the essential similarity of the veterinary medicinal product for which registration is sought, in relation to the veterinary medicinal product to which reference is made, must be demonstrated, for example, by a proof of bioequivalence or pharmaceutical, pharmacodynamic or therapeutic equivalence. In the case of applications using a reference, the proposed Summary of Product Characteristics usually corresponds to the current Summary of Product Characteristics referred to; However, where derogations exist in the proposed text, they shall be indicated in the proposal and justified. Where an appropriate reference product is registered, reference may not be made to a product registered in another Member State. The European reference product shall only be used if the appropriate reference product is not or has not been registered. Information is required on the country of origin of the European reference product and on the countries in which it is applied. The application submitted with the consent of the original holder shall be accompanied by such consent.
(5) The application for the simplified registration of a veterinary homeopathic product shall be accompanied by the documentation provided for in Title V of Annex 2 to this Regulation for the application for the simplified registration of veterinary homeopathic products.
(6) All relevant articles, including general articles and general chapters of the European Pharmacopoeia, shall be used for the dossier submitted with an application for authorisation of a veterinary medicinal product other than an immunological veterinary medicinal product for the part of the registration dossier affecting quality. All relevant articles, including general articles and general chapters of the European Pharmacopoeia, shall apply to immunological veterinary products for parts of the registration dossier which affect quality, safety and efficacy. With regard to the use of colouring matters in the veterinary preparation, the requirements laid down in Title VIII of Annex 2 to this Regulation shall apply.
(7) The dossier submitted with the application for registration of the veterinary medicinal product shows that the manufacturing processes of the veterinary product are carried out in accordance with the requirements for good manufacturing practice. The dossier further demonstrates that pharmacological, toxicological, residue and safety tests were carried out in accordance with the requirements of good laboratory practice.
(8) The dossier submitted with an application for registration of a veterinary product containing or consisting of a genetically modified organism contains an evaluation of the risk associated with the placing on the environment of a genetically modified organism under another regulatory provision (9).
(9) The dossier submitted with the application for registration of a veterinary medicinal product intended for minor species or for minor indications may not always contain all the information required in Annex 2, provided that this is provided for in the relevant Commission or Agency instructions.
(10) A single sample of the product shall be submitted with the application for a marketing authorisation or, where appropriate, before the marketing authorisation is granted, from each type of immediate packaging or, in agreement with the Veterinary Institute, models of all the internal and external packaging in which the veterinary product is to be placed on the market; a sample of the veterinary product may also be submitted from developmental batches whose characteristics correspond to those of the veterinary product which is the subject of the application.
Criteria for classification as reserved veterinary products, for assessing the interchangeability of the names of veterinary products and for deciding on classification with regard to the issue for veterinary products intended for animals from which animal products for human consumption are obtained
(1) The veterinary medicinal products reserved for use are:
(a) absorption antidiarrhoic agents;
(b) anti-septic medicinal products intended to treat the skin surface of the animal or from outside mucous membranes, including those where the skin or mucous membranes show signs of inflammation or are present with minor injuries; are also veterinary products intended for the treatment of pups of neonatal pups and skin derivatives of animals, veterinary products intended for the preparation of an operating field and intended for use on the mammary gland of bovine animals in order to prevent or treat mastitis,
(c) dermatology;
(d) derivatives;
(e) insecticidal or acaricide preparations intended for external administration, including veterinary medicinal products for the development of external parasites;
(f) oral rehydration solutions,
(g) vitamin and mineral preparations;
(h) dietetic preparations;
(i) oral antivirals that have an effect on their physical-chemical activity.
(2) When assessing the interchangeability of names under § 31 (5) (a) (4) of the Act, it shall be taken into account in particular whether the name in the printed, manuscript or pronounced form is not interchangeable with the name of another veterinary medicinal product. The assessment shall take into account the likelihood of a risk to public health, animal health or the environment.
(3) The conditions under which a marketing authorisation may provide that a veterinary medicinal product intended for animals from which animal products for human consumption are obtained may be issued without a prescription are laid down in Title VII of Annex 2 to this Decree.
Amendments to the marketing authorisation
In the case of an application for a change to the method of dispensing a medicinal product to a prescription without a prescription or without a prescription with a restriction or classification as a reserved medicinal product, the documentation submitted shall comply with the requirements set out in Annex 6 to this Regulation.
Transfer of registration
(1) The application for the transfer of a marketing authorisation shall contain, in addition to the particulars required by the Law on Medicines, the following particulars and documentation:
(a) the name of the product to which the transfer of marketing authorisation relates, its pharmaceutical form, strength and registration number;
(b) the name and, where applicable, the name, surname and place of business of the former marketing authorisation holder, if any, if it is a natural person, or the business name and registered office, if it is a legal person, and the name and, where applicable, the name, surname and place of business of the person to whom the decision is to be transferred, if it is a natural person, or the business name and registered office, if it is a legal person, and the draft date on which the transfer of the marketing authorisation is to take place;
(c) a statement by the marketing authorisation holder and the person to whom the decision is to be transferred, with their signatures, that a complete and updated dossier concerning the product or a copy of the dossier has been made available or transmitted to the person to whom the decision is to be transferred, corresponding to the dossier submitted by the Institute or the Veterinary Institute in the context of the registration procedure or, where appropriate, the modification procedure;
(d) proposals for a summary of product characteristics, package leaflet, packaging data and models of all the external and internal packaging in which the product is to be marketed, including colour graphic presentation, containing the name of the person to whom the decision is to be transferred; in addition to the particulars concerned by the transfer of the marketing authorisation, the draft summary of product characteristics, package leaflet and packaging particulars shall be identical to the approved summary of product characteristics, package leaflet and particulars on the packaging of the product.
(2) In addition to the information provided for in paragraph 1, a plan for the transfer of pharmacovigilance obligations under Title V of the Law from the existing marketing authorisation holder to the person to whom the decision is to be transferred shall be submitted. The transfer plan shall include, in particular, a formalised way of transmitting adverse reaction reports during the period when products with old contact data are on the market, a plan to ensure continuity of reassessment of the benefit / risk balance, and a way of transferring pharmacovigilance data and other relevant information.
(1) A code shall be assigned to the marketing authorisation holder for each package size or type of packaging (Section 32 (5) of the Act). A new code shall be assigned in the event of a change in the name of the medicinal product, package size and type of packaging, and in the case of a transfer of registration, taking over the marketing authorisation and simultaneous importation.
(2) The Institute or Veterinary Institute assesses the data submitted in the context of the fulfilment of the conditions under Article 32 (3) and (4) of the Medicines Act and, on the basis of this assessment, reassesses whether the benefit of the use of the product continues to exceed the risks associated with its use under the conditions defined by the Summary of Product Characteristics.
(3) Where the registrant of a veterinary medicinal product demonstrates that, in view of the need for the availability of the veterinary medicinal product for veterinary care and taking into account:
(a) preventing the suffering of animals;
(b) the rare occurrence of indications for which the veterinary medicinal product is intended,
(c) the need for effective veterinary measures to protect against diseases; or
(d) the current state of scientific knowledge;
is unable to submit complete data concerning the quality, safety or efficacy of the veterinary medicinal product before the completion of the veterinary medicinal product registration procedure, the marketing authorisation may be granted in accordance with Sections 32 (3) and (4) of the Medicines Act.
Extension of registration
The marketing authorisation holder shall submit to the application for renewal:
(a) contact details for the person responsible for pharmacovigilance, the contact person for communication on defects and withdrawal and the contact person for a publicly available technical product information service;
(b) evidence of compliance with the conditions of good manufacturing practice in the manufacture of the product, such evidence being not more than 3 years old, together with a declaration by the qualified person of the manufacturer responsible for the release of the product, that only the active substances manufactured in accordance with the principles of good manufacturing practice in the manufacture of the raw materials are used as starting materials; for production sites outside the territory of the European Economic Area and outside the States having an agreement with the Community on the mutual recognition of inspections of a good manufacturing practice (3), a list of inspections of good manufacturing practice carried out in the last 5 years, indicating the date, inspection team and inspection result, shall be submitted,
(c) the draft text of the Summary of Product Characteristics, both in its final form and of the text with any possible changes to the approved version; in the context of the renewal of the marketing authorisation, in addition to the changes to the Summary of Product Characteristics referred to in point (e), only the text adaptations to the Summary of Product Characteristics without changes in content are permitted;
(d) a draft of the package leaflet, both in its final form and a text with any possible changes to the approved version or, where appropriate, of the data on the packaging;
(e) in the case of a medicinal product for human use, an updated risk management plan and an addendum to the clinical review and to the pre-clinical review, to the extent specified in the Constitution guideline; where the medicinal product does not have a risk management plan, the marketing authorisation holder shall provide a justification for not submitting it,
(f) an addendum to the overall quality summary containing a statement by the product quality expert showing that the marketing authorisation holder introduces the necessary changes to enable the manufacture, quality control and use of the product in accordance with technical and scientific progress and with available scientific knowledge, and that any changes in the quality of the product are made after approval of the marketing authorisation application and that the product complies with the relevant guidelines of the Commission and the Agency; the statement must be signed by the expert and shall include brief information on the education, training and professional experience of the expert,
(g) in the case of veterinary medicinal products:
1. a statement by a clinical expert assessing the current risk-benefit balance of the product, including an assessment of the consequences of the procedure; This statement shall be made by the expert on the basis of comprehensive data and documentation on the medicinal product concerned, the information contained in the periodic safety update reports and any publicly available data; in the statement by the expert, confirm that no new pre-clinical or clinical data are available to influence the assessment of the current risk-benefit balance,
2. a statement by the safety expert assessing the safety of the user and, where the veterinary medicinal product is authorised for animals from which products for human consumption are obtained, the safety for consumers of foodstuffs obtained from treated animals; the expert statement summarises all new relevant information for the period under assessment; the expert shall also take into account the risk-benefit assessment of the use of the veterinary medicinal product for the environment;
3. the expert statement referred to in points 1 and 2 shall contain a clear statement as to whether the marketing authorisation may be extended for an unlimited period or only for a further period of 5 years, or, where appropriate, under which conditions, including justification; where this condition consists in making a change to the Summary of Product Characteristics aimed at ensuring a favourable benefit balance and the risk of its use, such change may be made in the context of the renewal of the marketing authorisation without a separate application for the modification of the marketing authorisation being submitted; the declaration shall be signed by the competent expert and shall be accompanied by brief information on the education, training and professional experience of the expert,
(h) in the case of a veterinary medicinal product, a periodic safety update report to cover the entire period since the marketing authorisation or the last renewal of the marketing authorisation, following the periodic safety update reports already submitted. If this period is covered by more periodic updates of product safety reports, an additional report or a summary bridging report shall be submitted to the Veterinary Institute as appropriate in accordance with the instructions of the Commission and the Agency,
(i) the approved specification of the active substance (s) and the finished product.
Taking over registration
The application for the authorisation of a medicinal product for human use from another Member State shall contain the following particulars and documentation:
(a) the name of the product to which the marketing authorisation relates, its pharmaceutical form, its strength, the Member State from which the marketing authorisation is to be taken over, the marketing authorisation number in that State and the date of the marketing authorisation;
(b) the name and, where applicable, the name, surname and place of business of the applicant, if any, if it is a natural person, or a business name and registered office, if it is a legal person;
(c) the name and, where applicable, the name, surname and place of business of the marketing authorisation holder in the Member State from which the marketing authorisation is to be taken over, if it is a natural person, or the business name and registered office, if it is a legal person;
(d) an affidavit by the applicant not to hold a marketing authorisation for the product in question in a Member State or by a person linked to it;
(e) the justification for the application, with evidence of the facts justifying the legal conditions for taking over the marketing authorisation;
(f) proof of registration in the Member State;
(g) the list of manufacturers involved in the repackaging, remarking and any other modifications of the product and the relevant manufacturing authorisations or evidence of compliance with good manufacturing practice shall be documented;
(h) the reference number and the date of issue of the distribution permit held by the applicant or the person responsible for distributing the product from the Member State concerned, where the distribution permit has been issued by the competent authority of another Member State of the Community, a copy of that authorisation shall be submitted;
(i) the way in which changes in the marketing authorisation of the product in the Member State concerned are to be monitored, where appropriate, the cessation or marketing of the product;
(j) the way in which pharmacovigilance is ensured,
k) graphic designs of the packaging of the product as intended for placing on the market in the Czech Republic, proposals for a summary of product characteristics, labelling and package leaflet. These proposals will be submitted in the Czech language, unless otherwise provided for under Section 38 of the Drug Act.
Concurrent imports
(1) In the application for authorisation of parallel imports, in addition to the information provided for in the Medicines Act, the following shall be indicated:
(a) the business name and registered office of the applicant, if it is a legal person, or the name or, where appropriate, the name, surname and place of business, if it is a natural person;
(b) the reference number and the date of issue of the distribution permit held by the applicant, where the distribution permit has been issued by the competent authority of another Member State of the Community, a copy of that authorisation shall be submitted,
(c) the way in which any cessation of output or marketing, changes in registration, suspension or withdrawal of registration of the reference product in the Czech Republic and the imported product in the relevant Member State of the Community will be monitored;
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Regulation Information
| Citation | Decree No. 228 / 2008 Coll., on the Registration of Medicinal Products |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.06.2008 |
|---|---|
| Effective from | 01.07.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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