Decree No. 288 / 2004 Coll.
Order setting out the details of the marketing authorisation of medicinal products, their changes, extensions, classification of medicinal products for dispensing, transfer of marketing authorisation, the issuing of authorisations for the simultaneous importation, submission and design of specific medical programmes using unauthorised medicinal products for human use, the way in which the adverse effects of the medicinal product are notified and evaluated, including the details of periodic safety update reports, and the manner and extent of the notification of the use of the non-authorised medicinal product (registration decree on medicinal products)
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Effective from 11.05.2004
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11.05.2004
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288
DECLARATION
of 29 April 2004
laying down details of the marketing authorisation of medicinal products, their changes, extensions, the classification of medicinal products for dispensing, the transfer of marketing authorisations, the submission and design of specific treatment programmes using non-authorised medicinal products for human use, the way in which the adverse effects of the medicinal product are notified and evaluated, including the details of periodic safety update reports, and the manner and extent of notification of the use of the non-authorised medicinal product (the marketing regulation on medicinal products)
Pursuant to Article 75 (2) (d) of Act No 79 / 1997 Coll., on medicinal products and on amendments and additions to certain related laws, as amended by Act No 149 / 2000 Coll. and by Act No 129 / 2003 Coll., (hereinafter referred to as "the Act"), Article 2 (6), § 5a (3), § 24 (5), Article 6 (a) and (b), and § 31a (10), § 24a (1) (c), (3) and (4), § 24b (2), § 26e (a) and § 11, § 26a (2), § 26b (2), § 26b (1), (2), (3), (9), § 26e (3), § 28 (e), § 31 (2), § 31a (6) and § 52a (b), § 1), § 1 (b), § 3, § 3, § 3, § 26d), § 26d.
Subject matter
(1) This Decree lays down, in accordance with the law of the European Communities (1), details of the marketing authorisation of medicinal products, changes thereto, extensions, classification of medicinal products for dispensing, transfer of marketing authorisations, the issue of authorisations for the simultaneous importation, submission and design of specific medical programmes using non-authorised medicinal products, the method of notification and evaluation of adverse effects of the medicinal product, including the formalities for periodic safety update reports, and the manner and extent of notification of the use of the non-authorised medicinal product.
(2) For the purposes of this decree:
(a) medicinal products for human use,
(b) veterinary medicinal products veterinary medicinal products,
(c) both medicinal products for human use (a) and veterinary medicinal products (b);
(d) vaccines, toxins and sera which, as a general rule, consist of immunological medicinal products for human use in accordance with Section 2 (6) of the Act:
1. vaccines used for active immunisation, such as diphtheria, tetanus and cough, polio, hepatitis A viral, hepatitis B viral, cholera, tuberculosis (BCG), smallpox,
2. preparations used for passive immunisation such as diphtheric antitoxin, smallpox globulin, antilymphocytic globulin,
3. preparations used to verify immunity, in particular tuberculin and tuberculin PPD, toxins for Schick test and Dick test, brucellosis,
(e) any medicinal product for human use that is intended to detect or induce specific changes in the immune response to an allergic agent,
(f) in principle similar products, such products which have both a qualitative and quantitative equivalent content of the same active substances, which may differ in the content of the excipients, their pharmaceutical form is identical and their bioequivalence with the reference product has been demonstrated by appropriate bioavailability tests; salts, esters, ethers and other derivatives of a given chemical are considered to be the same active substance if they do not differ in terms of safety and efficacy; fixed immediate-release oral formulations are considered to be identical,
(g) a new 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 Community (hereinafter referred to as the Community),
2. an isomer, a mixture of isomers, complex, derivative or salt of a chemical contained in a preparation already authorised within the Community but having different properties with regard to the safety and efficacy of the chemical,
3. a biological substance contained in a preparation already authorised within the Community but having a different molecular structure, the origin of the source of the raw material or the method of manufacture, or
4. the nature of the radiopharmaceuticals which are not yet included in any product already authorised within the Community or which are a mechanism for integrating radionuclide into a molecule which has not yet been used in any product authorised within the Community;
(h) 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;
(i) a biological medicinal product, the active substance of which is a biological substance; (2) advanced therapy products as defined in Part IV of Annex 1,
(j) nosodes such homeopathic products used for the preparation of pathological changes in tissues or pathogenic micro-organisms;
(k) the target animal species for which the veterinary medicinal product is intended.
Published data on the authorisation of an exemption from the veterinary medicinal product
The following information shall be published on the authorisation of the use of the non-authorised veterinary medicinal product:
(a) the name of the veterinary medicinal product, its pharmaceutical form, the qualitative and quantitative content of the active substances and the package size,
(b) the name and, where applicable, the name, surname and address of the manufacturer and distributor of the veterinary medicinal product, as well as the person who is its consignee, if any, if he is a natural person; the business name and registered office of the manufacturer and distributor of the veterinary medicinal product as well as the recipient, if any, of the legal person;
(c) the number of packages of the veterinary preparation, the conditions of supply, the supply and use, including indications, and the duration of the derogation.
Specific treatment programmes using unregistered human products
(1) The proposal for a specific treatment programme using non-authorised medicinal products for human use (hereinafter referred to as the "treatment programme") is submitted to the State Institute for Drug Control (hereinafter referred to as the "Institute") and the Ministry of Health. Its content is in addition to the data provided by law
(a) the name and address of the company and, where applicable, the name and address of the petitioner, if any, if it is a legal person, or the name or the name, surname and address of the natural person;
(b) the justification for the treatment programme, in particular the justification for the fact that the treatment programme is the subject of treatment, prevention or diagnosis of rare diseases, or any other exceptional need, and the conditions of serious human health threat, the condition which may cause death, life risk, the need for hospitalisation or prolongation of ongoing hospitalisation, may result in permanent or significant harm to human health or the emergence of incapacity for work; 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 data on the medicinal product used to the extent appropriate to pharmaceutical data submitted with an application for authorisation or a report of a clinical trial under a specific legislation; (3) in the case of medicinal products authorised abroad, such data may be replaced by a certificate of release of each batch of medicinal product used in the manufacturer's country; in the case of medicinal products for human use authorised in a Member State of the Community or in the European Economic Area, where appropriate, pharmaceutical data shall not be submitted if the summary of product characteristics referred to in point (e) is contained in the draft treatment programme;
(e) pre-clinical and clinical data to the extent appropriate to the investigator's file submitted in the application for authorisation of a clinical trial; (2) in the case of medicinal products for human use authorised abroad, such data may be replaced by a Czech text of the summary of product characteristics or other summary information for health professionals approved by the competent authority of the country where the medicinal product is authorised;
(f) the treatment programme plan in the structure corresponding to the protocol of the clinical trial, (2) containing the conditions of use of the human product, indicating the duration of the treatment programme,
(g) method of distribution and identifications4) persons providing distribution of the human product;
(h) the method of dispensing the human product;
(i) monitoring and evaluation of the safety and efficacy of the product;
(j) information for the patient in the Czech language appropriate to the information to be provided to the designated clinical trial subjects and, where appropriate, the package leaflet of the medicinal product;
(k) identification data (3) of the person responsible for checking the course of the treatment programme and data on the intervals for carrying out the control and the way in which it is documented;
(l) whether the initiation of the treatment programme is considered urgent;
(m) where appropriate, proof of reimbursement of the costs of the examination of the application.
If the draft specific treatment programme is not submitted by the manufacturer, distributor or marketing authorisation holder to a medicinal product for human use and is a programme of public interest or which may have particularly significant consequences for a wider range of persons, the Institute shall, upon request by the petitioner, provide synergies in the collection of the data referred to in points (c) and (d) to the extent available to it.
(2) The Institute shall draw up an opinion which it shall forward to the Ministry of Health. The Ministry of Health, taking into account this opinion, shall give written consent to the implementation of the treatment programme or reject the proposal, taking into account, where appropriate, the need for urgent initiation of the treatment programme. The outcome of the assessment shall be communicated by the Ministry of Health to the petitioner and the institute which, in case of consent, shall assign a code to the medicinal product for human use if it is for a medicinal product subject to registration.
(3) The following information shall be published on the treatment programme for which consent has been given:
(a) the name of the human product, its pharmaceutical form, the qualitative and quantitative content of the active substances in the human product, the size and number of packages, the manufacturer or, where appropriate, the distributor or the person importing the product from third countries;
(b) the name and, where applicable, the name, surname and address of the petitioner, if any, if it is for a natural person or a company or name, and its registered office, if it is for a legal person;
(c) the objective of the treatment programme and the duration of the consent.
Requirements for applications submitted and documentation
(1) Applications and other documentation submitted by the Institute for Human Products or the Institute for State Control of Veterinary Bioprafts and Medicines (hereinafter referred to as the Veterinary Institute), if applicable, must be made in legible form by means of typescript or printing. The application and documentation shall be submitted in duplicate unless otherwise agreed with the Institute, if it is for human products, or with the Veterinary Institute, if it is for veterinary products, in specific cases. The Institute, if it is for medicinal products for human use, or the veterinary institute, if it is for veterinary medicinal products, may waive the requirement to submit certain parts of the documentation by means of machine-copy or printing, or may request their submission electronically. The submission of an application and other documentation in electronic form shall be possible only after prior approval by the Institute, if it is for human products, or with the Veterinary Institute, if it is for veterinary products. The electronic format shall be used for the processing of the application and other documentation in electronic form, as instructed by the Institute.
(2) In addition to the information provided for by law, the application shall state:
(a) the trading firm and, where appropriate, the name and registered office of the legal person or the name, and, where applicable, the name, surname and address 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 the application is submitted by the person empowered by the applicant, it shall be accompanied by an authorisation with the official signature of the principal.
(4) Applications shall be accompanied by proof of payment of the administrative fee and proof of reimbursement of the costs of the examination of the application on the appropriate form, indicating the details enabling the payment to be clearly identified in accordance with the instructions of the competent institute. Where the applicant requests reimbursement of costs, he shall describe the facts justifying such a procedure.
(5) The application and documentation are submitted in Czech, Slovak or English. The draft summary of product characteristics, the particulars on the package leaflet and the package leaflet shall be submitted in the Czech language and, in the case of applications in writing, they shall also be submitted in electronic form. The completed application form shall always be submitted in electronic form. If the package leaflet is also included in the draft package leaflet, no separate draft package leaflet shall be required.
(6) The cases under Section 26d (1) of the Act are considered to be:
(a) such applications for marketing authorisations or applications for amendments in the labelling of the product in which the applicant expresses an interest in putting the information on the packaging in a language other than the Czech language; and
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 put into circulation does not exceed 2000 units per year, if the product is for human use,
3. The veterinary medicinal product is intended for minor animal species or for rare diseases and its availability in the Czech Republic is significant with regard to the protection of animal health, public health, environmental protection or welfare,
4. the proposal for an indication on the outer packaging shall be submitted in English, German or Slovak; and
5. an equivalent product is not registered and put into circulation with a packaging in the Czech language,
(b) such a request to allow the individual lots of the product to be put into circulation even if the particulars on the packaging are in a language other than the Czech language, provided that:
1. the product is subject to medical prescription,
2. an equivalent product is not registered and put into circulation with a packaging in the Czech language,
3. the number of packages of the batch of the product corresponds to the need to resolve the immediate shortage of the product, the label of which is in the Czech language, to the extent necessary,
4. the availability 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,
5. the lot of the product has been placed on the market in a Community State,
6. the labelling on the packaging is made in Latin, and the essential information is considered in particular to be the name of the product, strength, pharmaceutical form, active substance, holder of the marketing authorisation, storage method and shelf life, corresponding to the conditions of the marketing authorisation in the Czech Republic and can be derived from the text in a foreign language,
7. Each pack shall bear an approved package leaflet in the Czech language, supplied together with each individual package. If, in exceptional cases, this information is not included in the outer packaging, it must be attached externally or otherwise it must be ensured that the patient receives the relevant information when it comes to the medicinal product,
8. on the outer packaging or, where appropriate, on the inner packaging, if the outer packaging does not exist, they shall be accompanied, in particular by means of a copy or sticker, in the form of a bar code, by a 13-digit European code of goods (EAN), if it is for a medicinal product for human use, and by the registration number of the product in the Czech Republic; in the case of veterinary products, the 13-digit European Commodity Code (EAN) may be indicated on the packaging; and
9. The graphic presentation of the packaging is similar to that of the packaging marketed in the Czech Republic.
(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 a subsequent higher consumption of a human product than 2000 head per year, the marketing authorisation holder shall submit an application for a change to the marketing authorisation for labelling in the Czech language. Changes to the marketing authorisation referred to in paragraph 6 shall be considered as changes in the labelling of the product not related to the summary of product characteristics referred to in Article 26c (7) of the Act. Compliance with paragraph 6 (a) (1), (4) and (5) and compliance with paragraph 6 (b) shall be demonstrated by the applicant in the application and its annexes.
(8) The specification of procedures characterising individual types of applications or notifications and necessary supporting documents, including forms, shall be published in the Bulletin of the State Institute for Drug Control and on its website on the Internet and shall be available on request at the Institute for Human Products or at the Bulletin of the Institute for State Control of Veterinary Bioprafts and Medicines and on its website on the Internet and shall be available on request at the Veterinary Institute for Veterinary Products.
Types of applications for marketing authorisation
The following types of applications shall be submitted in the context of the registration procedure:
(a) a request which is supported by documentation in the full scope of the requirements laid down in Article 24 (5) of the Act and Annexes 1 to 5, hereinafter referred to as "a separate 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 a separate application or, where a further application for registration is requested, if a change is requested pursuant to Section 8 (8), significantly changing the existing registration of the product authorised on a separate application; a separate application is also made for a marketing authorisation based on the well-established therapeutic use of the active substances in the product contained in Article 24 (6) (b) of the Act ("the literary application '),
(b) the application, by reference to the results of the pharmacological and toxicological tests and the results of the clinical trials already submitted in the context of another marketing authorisation, by another marketing authorisation holder, provided that the products are essentially similar (§ 1 (f)), in accordance with § 24 (6) (a) or (c) and § 7 of the Act (hereinafter referred to as "the application with reference"); in the case of the application of the provisions of Paragraph 24 (6) (c) of the Act, the period laid down in that provision of the Act must expire at the latest by the date of application;
(c) a request for a simplified procedure for the registration of a homeopathic product in which no evidence of therapeutic efficacy is required (hereinafter referred to as "the application for a simplified registration of a homeopathic product") pursuant to Sections 24a and 24b of the Act; However, in the case of medicinal products for human use, this application may not be submitted for laying [§ 1 (j)] or for those products in which the content is:
1. basic tinctures higher than 1: 10 000 dilution,
2. essential substances higher than 1: 100 000 dilution; or
3. active substances higher than one hundredth of the smallest therapeutic dose.
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. These Annexes shall also apply to the submission of data and documentation for the purposes of the mutual recognition procedure (Section 27 (1) of the Act) where the Czech Republic is a reference Member State. 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 medicinal product shall be provided, as well as of the completed clinical trial, concerning the therapeutic indications not included in the application.
(3) All monographs, including general monographs and general stables of the European Pharmacopoeia, are applicable if part of the documentation is of quality (chemical, pharmaceutical and biological information). The certificate of conformity to the European Pharmacopoeia issued by the European Directorate for the Quality of Drugs, which replaces the parts of the dossier set out in this Annex, may be presented under the conditions laid down in position 1.
(4) A separate application shall be supported by the complete dossier set out in Annex 1. In the case of a literary application, the rules set out in point 1 of Part II of Annex 1 shall apply when attaching to a well-established therapeutic use. The application shall be accompanied by the relevant technical literature.
(5) For applications with reference, the data referred to in Annex 1, Part I of modules 1 and 3, the quality summary of Module 2 and the relevant parts of other modules shall be submitted, showing and justifying a substantial similarity. In addition, the documentation necessary for the assessment of those safety and efficacy aspects of the medicinal product for human use which are not included in the dossier referred to shall be submitted where appropriate; the essential similarity of the human product for which registration is sought, in the light of the human product referred to, for example, by means of a proof of bioequivalence or pharmacodynamic or therapeutic equivalence. In the case of applications with reference to the proposed Summary of Product Characteristics, the current Summary of Product Characteristics to which reference is made. 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. In the case of a request submitted with the consent of the original holder, such consent shall be supported by a declaration with an officially certified signature.
(6) 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. For modules 3 and 4, the data referred to in point 3 of Part III of Annex No 1 shall be submitted.
(7) Reserved medicinal products may be included
(a) medicinal teas and medicinal teas with the exception of medicinal teas and medicinal teas containing a strong or very strong active substance;
b) Multivitamin human products if their recommended daily dose does not contain more than 3333 units of vitamin or more than 400 units of vitamin D; such medicinal products may include minerals,
(c) adsorption anti-diarrhoeic agents containing activated charcoal if each pack of human product contains not more than 20 units of pharmaceutical form,
(d) antiemetics containing teklan moxastinium 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,
(e) 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,
(f) 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,
(g) human products intended for surface disinfection of minor skin injuries and disinsecticidal human products intended for external use;
(h) human medicinal products in the form of patches containing local-acting derivative active substances,
(i) medicinal products for smoking, containing nicotine.
(8) The indication of the symbol ® as a mark is an indication whose legitimacy is not verified by the Constitution (Section 26 (13) of the Act). When assessing the interchangeability of names under § 25 (7) (a) (6) of the Act, account shall be taken in particular of whether the name in a printed, 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.
(9) In addition to the documentation referred to in paragraph 4, 5 or 6, if a non-prescription human product is proposed to be delivered or classified as a restricted medicinal product, the documentation set out in Annex 6 shall be submitted. If a human product may present an increased risk of harm to health when used without the supervision of a doctor, or the possibility of frequent misuse or misuse, and as a result of which injury may occur, the dispensation of the human product shall be determined by the absence of a prescription.
(10) 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 (mock@-@ up) and one sample of the medicinal product shall be submitted from each type of immediate packaging; a sample of the human product from the development batch, the characteristics of which correspond to those of the human product which is the subject of the application, may be submitted. In justified cases, 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. These Annexes shall also apply to the submission of data and documentation for the purposes of the mutual recognition procedure (Section 27 (1) of the Act) where the Czech Republic is a reference Member State.
(2) When compiling and submitting registration dossiers, registrants shall take into account the instructions issued by the veterinary institute in accordance with the instructions issued by the Community institutions.
(3) 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 be provided. In addition, after the marketing authorisation has been granted, any information not included in the original application which is relevant for the assessment of the benefit / risk balance must be submitted without delay to the Veterinary Institute.
(4) A separate application shall be supported by the complete dossier set out in Annex No 2, Section I. In the case of a literary application, the requirements set out in Annex 2 shall apply mutatis mutandis to applications supported by experimental data; the rules set out in Annex No 2, Section III, shall apply when demonstrating a well-established therapeutic use.
(5) Applications with a reference shall not be submitted by experts pursuant to Article 24 (12) of the Act for those parts of the dossier for which reference is made to the results of pharmacological and toxicological tests and the results of clinical trials already submitted in the context of another marketing authorisation holder's other marketing authorisation. Where necessary, the documentation necessary for the assessment of those aspects of the safety and efficacy of the veterinary medicinal product which are not included in the dossier referred to shall be submitted with reference; 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. For applications with reference to the proposed summary of product characteristics, the current summary of product characteristics to which reference is made shall normally correspond; However, where derogations exist in the proposed text, they shall be indicated in the proposal and justified. The application submitted with the consent of the original holder shall be accompanied by such consent.
(6) The application for simplified registration of a veterinary homeopathic product shall be submitted in accordance with Annex 2, Section II; no expert reports and a draft SPC shall be submitted on the application for simplified registration of veterinary homeopathic products.
(7) The indication of the symbol ® as a mark is an indication whose legitimacy is not verified by the veterinary institute (Section 26 (13) of the Act). When assessing the interchangeability of names pursuant to Article 25 (7) (a) (6) of the 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 veterinary medicinal product. The assessment shall take into account the likelihood of a risk to public health, animal health or the environment.
(8) 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 internal and external packaging in which the veterinary product is to be placed on the market (mock@-@ up); a sample of the veterinary product may be submitted from developmental batches whose characteristics correspond to those of the veterinary product which is the subject of the application. In justified cases, the veterinary institute may waive the requirement to submit a sample.
Amendments to the marketing authorisation
(1) A change to the marketing authorisation shall be made where:
(a) amendments of an administrative nature (type I) which may be deemed to have been approved under the conditions laid down in Section 26a (2) of the Act and which are defined in Annex 7; or
(b) amendments (type II) not referred to in paragraph 8.
(2) An application for approval of a change against the dossier submitted in the framework of the marketing authorisation procedure, including the justification for the change, is submitted by the marketing authorisation holder. Each application for approval of a change to the marketing authorisation shall be accompanied by a proposal for the modified parts of the registration dossier concerned by the proposed change, including the proposals for packaging data, package leaflet and the Summary of Product Characteristics, where the proposed change appears. All proposed amendments shall be marked in relation to the original version.
(3) Where the amendment concerns a part of the dossier for which a certificate of conformity with the European Pharmacopoeia was initially submitted, the dossier required for the amendment shall be submitted to the European Directorate for the Quality of Medicines and the Institute or to the Veterinary Institute in case of revision of the certificate, an application for a variation of the marketing authorisation type I type 15 or 21 as set out in Annex 7, as the case may be. If the certificate initially submitted for several registrations of different products has been revised, an application shall be submitted for amendment of the marketing authorisation for all the products concerned.
(4) In the case of changes made only in order to comply with the updated monograph of the European Pharmacopoeia or national pharmacopoeia of a Member State of the Community and where compliance with the updated monograph is carried out within 6 months of the publication of the relevant update, it is not necessary to apply for the amendment of the marketing authorisation provided that the dossier contains a general reference to the valid pharmacopoeia without specifying its specific version.
(5) In the event of a change in the manufacturing process of non-protein components related to the subsequent integration of the biotechnology step, the Type I variation No 15 or, where applicable, No 21 may be used in accordance with Annex No 7. This specific amendment is without prejudice to the other amendments listed in Annex 7 which may be applied in this specific context. The inclusion of the protein component obtained by the biotechnology process referred to in the Community Regulation on Community procedures for the registration and supervision of medicinal products1) into the preparation shall be carried out in accordance with this Community Regulation. For specific product groups:
(a) food and food ingredients covered by the Community Regulation concerning novel foods and novel food ingredients, 5)
(b) colours for use in foodstuffs;
(c) food additives;
(d) extraction solvents;
(e) food or food ingredients obtained by a manufacturing process with the introduction of a biotechnology step;
there is no need to notify a change in the production process as a change in the registration provided that the Community legislation applicable to these groups is complied with. 6)
(6) In the case of a request for a change in the method of dispensing a prescription-related product to a dispensation without a prescription or classification as a reserved medicinal product, the documentation submitted shall comply with the requirements set out in Annex 6.
(7) In the application for approval of a change to the marketing authorisation, the marketing authorisation holder shall indicate the date from which only the product with the change is intended to be put into circulation.
(8) The amendment of the marketing authorisation may not be requested if the nature, characteristics or method of use of the product changes significantly (Section 26 (2) of the Act); in that case, the applicant submits a new application for registration. The following cases are concerned:
(a) the addition or deletion of one or more active substances, including the antigenic components of vaccines;
(b) replacement of the active substance by its different salt, complex or derivative with the same active ingredient, different isomer, different mixture of isomers or replacement of the mixture with an isolated isomer (e.g. racemate with one enantiomer),
(c) replacing a biological substance or a biotechnology product with another slightly different molecular structure; modification of the vector used in the production of antigen or raw material source, including a new cell bank of basic cells from another source,
(d) radionuclide incorporated in a new way into a molecule or a new carrier;
(e) modification of the extraction solvent or the ratio of the herbal substance to the plant preparation;
(f) a change in pharmacokinetic properties including a change in bioavailability resulting in loss of therapeutic equivalence with the original product, such as a change in the rate of release of the active substance;
(g) modification or addition of new force or activity, where appropriate;
(h) amendment or addition of a new route of administration; a distinction should be made between intraarterial, intravenous, intramuscular, subcutaneous and other routes for parenteral administration; in poultry, the respiratory, oral and ocular pathways (as aerosol) used for vaccination are considered equivalent,
(i) a change in the pharmaceutical form or a new pharmaceutical form;
(j) the addition or modification of the target animal species if it is a veterinary medicinal product intended for administration to animals from which foodstuffs intended for human consumption are obtained;
(k) shortening of the withdrawal period where the veterinary medicinal product is intended for administration to animals from which foodstuffs intended for human consumption are obtained.
(9) In cases of type I changes, irrespective of the product type, the Institute or the Veterinary Institute may issue a communication on the approval of the amendment. If there is a change in type I referred to in the second sentence of Paragraph 10 (1), the Institute or the Veterinary Institute shall always give such notification within 15 days of the date on which the change can be considered approved.
(10) In the event of a change in the labelling of the product or a change in the package leaflet which is not related to the summary of the product characteristics, in accordance with Section 26c (7) of the Act, the reasons for the change and the proposals for labelling or package leaflet shall be submitted together with the notification of such change.
Transfer of registration
The application for a marketing authorisation to another legal or natural person submitted by the marketing authorisation holder shall contain, in addition to the particulars required by law, the following particulars and documentation:
(a) the name of the product to which the marketing authorisation relates, its pharmaceutical form, strength, registration number and date of issue of the marketing authorisation;
(b) the name and, where applicable, the name, surname and address of the previous marketing authorisation holder, if any, if it is a natural person, or a business name, or a business name, or a registered office, if it is a legal person, and the name and, where appropriate, the name, surname and address of the person to whom the decision is to be transferred, if it is a natural person, or a business name, or a registered office, if it is a legal person, and a proposal for the date on which the transfer of the marketing authorisation is to take place;
(c) a declaration by the marketing authorisation holder and the person to whom the decision is to be transferred, with officially certified 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 to the institute or veterinary institute in the context of the marketing authorisation procedure or, where appropriate, the marketing authorisation amendment procedure;
(d) the documents submitted pursuant to Article 26b (1) of the Act by the person to whom the decision is to be transferred shall include in particular:
1. the name, name, surname, contact address, telephone and electronic connection of the qualified person responsible for pharmacovigilance pursuant to § 52a (1) or § 52e (1) of the Act,
2. as regards medicinal products for human use, the address of the publicly available professional product information service referred to in Article 26 (9) (g) (1) of the Act, including contact details;
(e) proposals for the summary of product characteristics, labelling and package leaflet indicating the name or name of the person to whom the decision is to be transferred, such proposals, in addition to administrative data, must be identical to the approved summary of product characteristics, labelling and package leaflet of the product concerned;
(f) the plan for the transfer of pharmacovigilance obligations (Sections 52 to 52g of the Law) from the existing marketing authorisation holder to the person to whom the decision is to be transferred, in particular the formalised way of transmitting adverse reactions reports during the period when products with old contact data are on the market and the plan to ensure continuity of reassessment of the benefit / risk balance, in particular the way in which pharmacovigilance data and other relevant information are transferred.
(1) Where a marketing authorisation is issued for several product variants, the marketing authorisation holder shall be assigned a code (Section 26 (7) of the Act) for each package size or type of packaging, if applicable. The code shall also be assigned in the case of changes to type I listed in Annex No 7, under points 2 and 41, where applicable, when the marketing authorisation referred to in Section 9 is transferred.
(2) Following the entry into force of a marketing authorisation or following a change in the appearance of the product or its packaging, one sample of the product packaging shall be presented to the Institute, if it is for human products, or to the Veterinary Institute, if it is for veterinary products. In justified cases, the competent institute may waive this requirement.
(3) The Institute or the Veterinary Institute assesses the data submitted in the context of the fulfilment of the conditions under Article 26 (6) (a) of the Act and, on the basis of that assessment, reassesses whether the benefit of the use of the product under the conditions defined by the Summary of Product Characteristics continues to exceed the risks associated with its use.
(4) 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 registration procedure, the marketing authorisation may be granted in accordance with Article 26 (6) (a) of the Act.
Extension of registration
The marketing authorisation holder shall submit to the application for renewal:
(a) evidence of compliance with the conditions of good manufacturing practice in the manufacture of the preparation, which may not exceed three years;
(b) a statement by a clinical expert taking into account the current therapeutic benefit balance and the risks from its use, including an assessment of the consequences of the mode of delivery; This statement shall be made by the expert on the basis of the information contained in the periodic safety update reports and any publicly available data; the statement of the clinical expert shall contain a clear statement as to whether the marketing authorisation may be extended or 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 a change to the marketing authorisation being 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, and of the Summaries of Product Characteristics approved by foreign control authorities; in the context of the renewal of the marketing authorisation, in addition to changes to the Summary of Product Characteristics referred to in point (b), only the text adaptations of 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) the periodic safety update report or, where appropriate, the supplementary report referred to in Article 13, so that, following the periodic safety update of the medicinal product already submitted, the whole period from the issue of the marketing authorisation or the last renewal of the marketing authorisation, if applicable, is covered or the documents submitted in accordance with the instructions of the veterinary institute, if applicable. Where this period is covered by more periodic updates of the safety reports of the medicinal product for human use and, where appropriate, an additional report, the Institute may further require the submission of a summary bridging report for that period,
(f) one sample of the preparation in each approved type of immediate packaging; where justified, the institute, if it is for a medicinal product for human use or the veterinary institute, if it is for a veterinary medicinal product, may waive this requirement. A sample of the product is submitted for circulation in the Czech Republic. If the product is not put into circulation in the Czech Republic, the information on the packaging provided for in Annex 5 shall be submitted.
Concurrent imports
(1) The application for authorisation of parallel imports shall, in addition to the information provided for by law, always indicate:
(a) the business name or name of the company and the registered office of the applicant, if it is a legal person, or the name or name, surname and address, 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;
(d) the way in which pharmacovigilance is ensured.
(2) In the case of parallel imports of a product from Estonia, Lithuania, Latvia, Hungary, Poland, Slovakia or Slovenia, in respect of a product in respect of which a patent or supplementary protection certificate has been granted in the Czech Republic at the time when such protection could not be granted in the State of importation, the applicant shall indicate in the application whether the applicant has informed the holder of the patent or supplementary protection or the person entitled to such protection relating to the imported product at least one month before submitting the application.
(3) The outer packaging of the product which is the subject of the parallel import or, where appropriate, its inner packaging, if necessary, shall contain, in an appropriate manner, in particular by means of a copy or sticker, the essential information corresponding to the conditions of the marketing authorisation in the Czech Republic, which cannot be easily derived from the text in a foreign language, and any information not provided in Latin. In particular, the name of the product, strength, pharmaceutical form, active substance, marketing authorisation holder, storage method and shelf life shall be taken as basic data. It shall be completed in the form of a bar code of the 13-digit European Commodity Code (EAN) different from the reference product code, if applicable for human products, with the registration number of the reference product in the Czech Republic supplemented by the unique identification given in the parallel import authorisation and the holder of the parallel import authorisation. The European Code of Goat (EAN) may be added to the outer packaging of veterinary products.
(4) If the imported product is re-packaged in a new outer packaging, the information in Annex 5 shall be provided in accordance with the terms of the registration of the reference product in the Czech Republic and shall be completed in the form of a bar code of the 13-digit European Commodity Code (EAN) different from that of the reference product if it is for human products and the holder of the authorisation for simultaneous importation. The registration number of the reference product in the Czech Republic shall be supplemented by the unique identification given in the authorisation of parallel imports. The European Code of Goat (EAN) may be added to the outer packaging of veterinary products.
Periodic safety update of the medicinal product
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Regulation Information
| Citation | Decree No. 288 / 2004 Coll., laying down the details of the marketing authorisation of medicinal products, their changes, extensions, classification of medicinal products for supply, transfer of marketing authorisation, the issuing of authorisations for the simultaneous importation, submission and design of specific medical programmes using non-authorised medicinal products for human use, the notification and evaluation of adverse effects of the medicinal product, including the need for periodic safety update reports, and the manner and scope of the notification of the use of the non-authorised medicinal product (the marketing regulation on medicinal products) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 11.05.2004 |
|---|---|
| Effective from | 11.05.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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