Decree of the Ministry of Health and the Ministry of Agriculture No. 289 / 1998 Coll.
Ordinance of the Ministry of Health and of the Ministry of Agriculture laying down details of the marketing authorisation of medicinal products and the scope of the published information on the authorisation of the use of an unregistered medicinal product
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Order
Effective from 10.12.1998
Text versions:
10.12.1998
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289
DECLARATION
Ministry of Health and Ministry of Agriculture
of 25 November 1998
laying down the details of the marketing authorisation of medicinal products and the scope of the published information on the authorisation of the use of the non-authorised medicinal product
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to § 75 (2) (d), according to § 24 (1), § 27 (1) and § 31 (4) of Act No. 79 / 1997 Coll., on medicinal products and on amendments and additions to certain related laws (hereinafter referred to as "the Act '):
For the purposes of this decree:
(a) the strength of the medicinal product of the quantity of the active substance in the unit of the pharmaceutical form for the fixed formulations, for the liquid and gaseous formulations of the active substance concentration or, where appropriate, the resulting concentration of the active substance in the medicinal product (hereinafter referred to as "the product") intended for administration, if dilution, dissolution or other modification is carried out in accordance with the instructions of the marketing authorisation holder;
(b) products essentially similar to those which have both a qualitative and quantitative equivalent content of the active substances may differ in the content of the excipients, have the same method of use and their pharmaceutical form is similar.
Scope of the published authorisation data for the use of an unregistered product
The following information shall be published on the authorisation of the use of unregistered preparation (1):
(a) the name of the product, its pharmaceutical form, the qualitative and quantitative content of the active substances in the product and the package size,
(b) the name, surname, address of the manufacturer of the product, if any; name (trade name) and registered office, if applicable,
(c) the name, surname and address of the natural person or the name (trade name) and registered office of the legal person authorised by the derogation, 1)
(d) the number of packages.
Requirements for applications submitted and documentation
(1) Applications and other documentation submitted to the State Institute for the Control of Medicinal Products (hereinafter referred to as "the Institute"), if they are for human products, or to the Institute for the State Control of Veterinary Bioprafts and Medicines (hereinafter referred to as "the Veterinary Institute"), if they are for veterinary products, must be made in legible form by means of a machine or print. The application and the documentation shall be submitted in duplicate. Individual parts of the documentation shall be presented separately, with continuously numbered pages and in sheets allowing leaf release. The content of each part of the dossier shall be indicated.
(2) The application shall indicate in particular:
(a) the trade name and registered office of the applicant, if he is a legal person, or his name, surname and address, if he is a natural person;
(b) the trade name and registered office of a legal person in the Czech Republic, or the name, surname and address of a natural person in the Czech Republic, where that person submits an application by authorization of the applicant;
(c) the name of the preparation, its pharmaceutical form and, in the case of single-component preparations, the strength of the preparation,
(d) a proposal for the method of dispensing the preparation;
(e) the product registration number if there is a request for amendment, extension or withdrawal of the marketing authorisation.
(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.
Types of applications for marketing authorisation
(1) The following types of applications shall be submitted in the context of the registration procedure:
(a) an application which does not use the data submitted in the context of another registration procedure, hereinafter referred to as "a separate application,"
(b) the application using a reference to data already submitted in the context of another registration procedure (hereinafter referred to as "the application with reference").
(2) An application with reference may be submitted by the applicant if:
(a) holds a marketing authorisation the marketing authorisation of which submitted the data referred to; or
(b) submit the written consent of the marketing authorisation holder for which the data referred to have been submitted at the time of registration using this information, (2); or
(c) reference is made to data submitted in the context of another marketing authorisation procedure by another marketing authorisation holder whose release has been completed for at least 6 years. 3)
Documentation submitted with registration
(1) In particular, the documentation submitted shall show and justify:
(a) compliance with good manufacturing practice in the manufacture of the product;
(b) the reliability of the conditions under which the information in the dossier was obtained;
(c) the efficacy of the product in all proposed indications,
(d) the proposed dosage, taking into account in particular the age, weight, sex and nature of the diseases treated by humans or animals, in animals also the type of animal;
(e) the safety of the product in the light of both preclinical and clinical data, in situations foreseeable in clinical practice, including procedures to reduce adverse reactions;
(f) the fact that the therapeutic benefit outweighs the risk from its use, taking into account the current treatment options in the indication area,
(g) the trueness of the product information contained in the SPC.
A dossier shall be submitted with the application for marketing authorisation, the content and the breakdown of which are set out in Annexes 1 to 4 to this Decree.
(2) The scope of the dossier submitted with the application corresponds to the knowledge of the product, its nature, the benefits it brings and the risks associated with its use. The documentation shall include all existing information relevant to the assessment of the risk-to-benefit ratio of the product; Information on tests and assessments of uncompleted or uncompleted tests shall also be provided.
(3) A separate application must be supported by complete documentation, the results of a pre-clinical and clinical trial of the product being replaced by references to reliable and complete data in the literature. The scope and breakdown of the complete dossier are set out in Annex 1 to this Decree.
(4) The application with a reference shall be accompanied by the documentation necessary for the assessment of those aspects of the quality, safety and efficacy of the product which are not included in the dossier referred to; in the case of essentially similar products, their similarity for the use of data already submitted is demonstrated in particular by a proof of bioequivalence or pharmacodynamic or therapeutic equivalence.
(5) In addition to the documentation referred to in paragraphs 4, 5 or 6, the documentation set out in Annex 5 to this Decree shall also be submitted if a product is proposed to be delivered without a prescription. If, when used without medical supervision, the product presents an increased risk of harm, no prescription may be given.
(6) A single sample of each type of immediate packaging shall be submitted with the application for a marketing authorisation or, where appropriate, before the marketing authorisation is granted. In the case of veterinary products, samples of the product shall be submitted with the application for registration in such quantities as to enable 3 analyses to be carried out according to the applicant's control methods; These samples shall be submitted with the manufacturer's attest.
Changes in registration
(1) A change to the registration shall be made in the case of:
(a) amendments of an administrative nature (type I) as defined in Annex 6 to this Decree; or
(b) amendments (type II) not referred to in paragraph 5.
(2) The application for approval of a change to the dossier submitted in the framework of the marketing authorisation procedure is submitted by the marketing authorisation holder. Each application for approval of a change to the marketing authorisation shall be submitted with a proposal for the modified relevant parts of the registration dossier concerned by the proposed change, including the proposals for packaging data, package leaflet and a summary of the product characteristics, where the proposed change appears.
(3) In the case of an application for a change in the method of dispensing the product from a prescription to a dispenser without a prescription, the documentation submitted shall comply with the requirements set out in Annex 5 to this Regulation.
(4) In the application for approval of a change in the marketing authorisation, the marketing authorisation holder shall indicate the date from which only the product with the change in the product will be put into circulation; that date shall be determined in such a way that the period after approval of the change in the marketing authorisation is not more than 180 days.
(5) Paragraphs 1 to 4 shall not apply where the nature, characteristics or method of use of the product changes significantly; in which case a new application for a marketing authorisation is required. 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, isomer or mixture of isomers, complex or derivative with the same active component of the molecule;
(c) the different molecular structure of the active substance of biological or biotechnology origin, the change of the cell bank in the case of a biotechnology preparation, the modification of the vector used to prepare the antigenic material or its source;
(d) radionuclide incorporated in a new way into a molecule or a new carrier;
(e) extension of the indication to a new area of therapeutic, diagnostic or preventive use;
(f) the transfer of the indication to a new area of therapeutic, diagnostic or preventive use of the product;
(g) a change in the pharmacokinetic properties resulting in loss of therapeutic equivalence with the original product;
(h) the new strength of the preparation,
(i) a new route of administration;
(j) the change in the dosage form or the new formulation.
Extension of registration
The marketing authorisation holder shall submit to the application for renewal:
(a) proof of compliance with the conditions of good manufacturing practice in the manufacture of the preparation;
(b) the summary of the product characteristics and, where appropriate, the summary of the product characteristics approved by the foreign control authorities;
(c) package leaflet,
(d) a summary report on the evaluation of adverse reactions, supplemented by a qualified analysis (product safety report), the content and breakdown of which are listed in Annex 7 to this Regulation,
(e) a list of changes to the marketing authorisation made since the marketing authorisation was granted or, where applicable, the last renewal of the marketing authorisation, if the marketing authorisation has already been extended;
(f) one sample from each registered type of immediate packaging.
Efficacy
This decree shall take effect on the day of its publication.
Minister for Health:
Dr. David, CSc.
Minister for Agriculture:
Ing. Fencl v. r.
Příloha č. 1
Annex No 1 to Decree No 289 / 1998 Coll.
Content and breakdown of the complete registration dossier
1. Part IA - Administrative data on the product - contains in particular:
(a) an application indicating in particular:
1. type of application for registration,
2. the name of the product which, in the case of an application for a marketing authorisation of a product produced in various strengths, contains data on the strength of the product and, where the name is a generic or international non-proprietary name of the active substance, contains an identifier enabling the products of different applicants to be distinguished; under one application, the product may only be registered under one name,
3. the composition of the case, its route of administration, package size and type of container,
4. an indication whether the applicant proposes that no prescription should be given for the authorised product,
5. where the veterinary medicinal product is concerned, the data on the proposed withdrawal periods and the data on the withdrawal periods approved by the foreign control authorities;
(b) the identification of the manufacturers involved in the manufacture of the product with information on their role in the production chain and their production authorisation documents for all production sites indicated in the application, including confirmation of compliance with the requirements of good manufacturing practice;
(c) the identification of manufacturers of active substances;
(d) a list of States in which:
1. the product is authorised, including the indication of the year of registration and the registered name;
2. the registration is applied for or where the application for a marketing authorisation has been withdrawn or refused, including a statement of reasons;
3. the marketing authorisation has been revoked, suspended or re-authorised, stating the reasons;
(e) the list of parts of the application, including the list of pages.
Part IB contains in particular:
(a) a draft summary of product characteristics as set out in Annex 2 to this Regulation;
(b) a draft package leaflet as set out in Annex 3 to this Order,
(c) draft texts and data placed on the inner and outer packaging as set out in Annex 4 to this Decree;
(d) copies of the summary of product characteristics approved by the foreign control authorities.
3. Part IC contains analyses of the properties of the product documented in Parts II, III and IV of the registration dossier (hereinafter "expert reports'). The reports of experts on individual works of registration documentation shall include in particular:
(a) a brief profile of the essential characteristics of the preparation,
(b) summaries of data in the film tables,
(c) a brief summary of the content;
(d) a critical assessment of the content of the relevant part, including an assessment of the completeness of the supporting documents, the reliability of the data submitted and the consistency of the data with the draft SPC.
The reports of experts shall be accompanied by data on the education and practice of their authors; reports shall be submitted with the author's signature. If available, evaluation reports shall be attached by foreign control authorities.
Part II contains the chemical, pharmaceutical and biological documentation of the product. All control methods shall be sufficiently described to enable them to be carried out by the control laboratory and validated; Part II consists of the following parts:
(a) IIA - composition of the preparation,
(b) IIB - description of production,
(c) IIC - control of starting materials, including the method of extraction and processing of raw materials for the manufacture of biological products,
(d) IID - control methods for intermediate products,
(e) IIE - control methods for the finished product, including atests of 3 batches of the product, a test of 1 batch of the product, and a promise of delivery and tests of 2 batches as soon as available; the tests must be submitted for all production sites indicated in the application,
(f) IIF - stability studies,
(g) IIG - bioequivalence and, where appropriate, bioavailability,
(h) IIH - environmental risk assessment data for products containing genetically modified organisms,
(i) IIQ - other data,
(j) IIV - a dossier demonstrating safety with regard to the transmission of viruses or other infectious diseases agents, if it is biological products.
Part III contains a pharmacologic-toxicological dossier. For each animal study, in particular, the animal species used, their sex, age, weight, housing and feed shall be reported and identified in the study; Part III consists of the following parts:
(a) IIIA - toxicity containing single and repeated dose toxicity studies; Where veterinary products are concerned, data on residues in the organism and livestock products shall be provided in accordance with the maximum permitted levels laid down;
(b) IIIB - influence of reproductive functions,
(c) IIIC - embryotoxicity, foetotoxicity and perinatal toxicity,
(d) IIID - mutagenic potential in vitro and in vivo,
(e) IIIE - carcinogenicity,
(f) IIIF - pharmacodynamics containing pharmacodynamic actions related to the proposed indications, general pharmacodynamics and drug interactions,
(g) IIIG - pharmacokinetics which include single dose pharmacokinetics, repeated dose pharmacokinetics, distribution in both pregnant and non-pregnant animals and biotransformation,
(h) IIIH - local tolerance,
(i) IIIQ - other data,
(j) IIIR - ecotoxicity, including environmental risk assessment.
1. Part IV contains the clinical documentation and consists of the following parts:
(a) IVA - clinical pharmacology, broken down into pharmacodynamics and pharmacokinetics data; in the pharmacokinetic data, knowledge obtained in healthy persons, in patients and in special groups of persons, or in specific pathological conditions, if applicable, if applicable, in human products, in target animals, if applicable,
(b) IVB - clinical experience which is divided into the results of clinical trials, post-marketing experience, including observed adverse reactions, the number of exposed persons or animals and the safety reports available and information on ongoing and incomplete clinical trials,
(c) IVQ - additional data.
2. The results of clinical trials shall be submitted in the form of summary reports, in particular containing:
(a) a brief description of the clinical trial and its results;
(b) a description of the arrangements and manner of evaluation;
(c) the results showing the group characteristics of the assessment bodies, the efficacy and safety data, the statistical evaluation of the conclusions, the data obtained from individual subjects in the form of tables, the records of the evaluation bodies being submitted only on request;
(d) the risks to the environment if they are for veterinary products;
(e) residue studies in tissues and products of target animals, if applicable,
(f) analysis of results and conclusion,
(g) Annexes to support the details of the data referred to in (b) and (c) and references to professional literature.
If a part of the dossier is not incorporated, the justification shall be given at the appropriate place.
Příloha č. 2
Annex No 2 to Decree No 289 / 1998 Coll.
Content and breakdown of the SPC
The summary of product characteristics shall include the following:
1.
2. Composition of both qualitative and quantitative
Only active substances are listed using their international non-proprietary names; in the absence of such names, generic names shall be used.
3. Pharmaceutical Form
The pharmaceutical form is the resulting form of the product, which is determined by the pharmaceutical form of the product, the method of administration and, where appropriate, the type of packaging.
4. Clinical data
4.1. Indications
4.2. Posology and method of administration
Indicate
4.2.1. Dosage for individual age categories and dosage for hepatic, renal failure or dialysis if human products are used, or dosage for individual age categories of target animals if veterinary products are used; the dosage is described by dose size, dose interval and duration of treatment,
4.2.2. the maximum daily dose and the maximum dose for the entire treatment,
4.2.3. Recommendations for monitoring drug plasma levels or other indicators of its effects.
4.3. Contraindications
4.4. Special warnings
Indicate
4.4.1. warning of the adverse reactions of the pharmacodynamic group to which the product is classified or of the product under normal use,
4.4.2. warning for adverse reactions that occur in special cases, especially in the elderly and in renal, hepatic or cardiac failure,
4.4.3. a description of how the product is used in patients at risk groups,
4.4.4. procedures to prevent adverse reactions.
4.5. Interaction
4.5.1. Only clinically relevant interactions with products used for the same indication, interactions with other indications and interactions related to the way of life, such as interactions with food, are reported.
4.5.2. For each interaction, a mechanism shall be provided, if known; effect on plasma levels of the active substance and on laboratory and clinical parameters; the contraindication to co-administration with other medicinal products and any precautions when taken with other medicinal products, in particular dose adjustment.
4.6. Pregnancy and lactation
Indicate
4.6.1. results of reproductive and fertility studies in animals; if it comes to human medicine, experience with humans and risk assessment during individual periods of pregnancy,
4.6.2. The possibility of using the product in pregnant women and women of childbearing potential,
4.6.3. Recommendation whether to continue breast-feeding with indication of the likelihood and severity of adverse reactions in the child; these data are reported when the active substance or its metabolites are excreted in human milk, when it is for human products; the possibility of use in pregnant animals with indication of the likelihood of adverse reactions in young animals, if applicable for veterinary medicinal products.
4.7. The possibility of reduced attention when driving or operating machinery
An indication of the effect of attention shall be provided. Based on the pharmacodynamic profile, the adverse reactions reported and the effects on the ability to drive and use machines, the medicinal products are divided into 3 categories of affected patients.
4.7.1. safe or unlikely to be affected,
4.7.2. with a probability of slight interference,
4.7.3. with a likelihood of significant influence, potentially dangerous;
a warning shall be provided in cases of likely moderate or significant interference.
4.8 Undesirable effects
A list of adverse reactions, frequency and severity shall be provided.
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Regulation Information
| Citation | Decree of the Ministry of Health and the Ministry of Agriculture No. 289 / 1998 Coll., laying down details of the marketing authorisation of medicinal products and the scope of the published information on the authorisation of the use of an unregistered medicinal product |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 10.12.1998 |
|---|---|
| Effective from | 10.12.1998 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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