Decree No. 302 / 2003 Coll.
Decree amending Decree No. 473 / 2000 Coll., laying down the details of the marketing authorisation, its amendments, extensions, the method of dispensing the medicinal product, the method of notification and evaluation of the adverse effects of the medicinal product and the manner and extent of notification of the use of the non-authorised medicinal product
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18.09.2003
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302
DECLARATION
of 3 September 2003
amending Decree No 473 / 2000 Coll., laying down the details of the marketing authorisation, its amendments, extensions, the method of dispensing the medicinal product, the method of notification and evaluation of the adverse effects of the medicinal product and the manner and extent of notification of the use of the non-authorised medicinal product
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to § 26b (1), § 27a (5), § 31a (6), § 52a (1) (b) and § 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. 129 / 2003 Coll., hereinafter referred to as "the Act":
Decree No. 473 / 2000 Coll., laying down the details of the marketing authorisation, its amendments, extensions, the determination of the mode of dispensing the medicinal product, the method of notification and evaluation of the adverse effects of the medicinal product and the manner and extent of notification of the use of the non-authorised medicinal product, shall be amended as follows:
1. in § 1 (a) to (d):
"(a) the vaccines, toxins and sera consisting of immunological medicinal products for human use as provided for in Article 1 (6) of the Act shall always be considered as:
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,
(b) allergenic product means any product which is designed to detect or induce specific acquired changes in the immune response to an allergic agent;
(c) 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,
(d) a new active substance which is:
1. chemical or biological nature or nature of radiopharmaceuticals and not yet included in any product authorised within the European Union;
2. an isomer, a mixture of isomers, complex, derivative or salt of a chemical contained in a preparation already authorised within the European Union 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 European Union but having a different molecular structure from that biological substance, 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 European Union or a mechanism for integrating radionuclide into a molecule which has not yet been used in any product authorised within the European Union, '.
Points (c) and (d) shall be renumbered as points (e) and (f).
2. In Section 2, "4 'is replaced by" 2';
3. in Paragraph 2 (b):
"(b) the name and, where applicable, the name and surname, the place of permanent residence of the manufacturer and the distributor of the product, as well as the person receiving the product, if any, if any, the natural person; the name and registered office of the manufacturer and distributor of the product as well as the recipient of the product, if any, ';
4. The following Section 2a is inserted after Section 2, including the title and footnotes 1) to 4):
Specific treatment programmes using non-authorised medicinal products for human use
(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) identification data (1) of the applicant;
(b) the justification for the treatment programme (Section 31a of the Act), in particular the justification for the fact that the treatment programme is the subject of treatment, prevention or diagnosis of a rare disease, or any other exceptional need, and is a serious threat to human health, and a condition which is considered to be a serious threat to human health is a condition which may cause death, endanger life, require hospitalisation or extension of the ongoing hospitalisation, may result in permanent or significant damage to health or the emergence of occupational incapacity; other treatment procedures, prevention or diagnosis considered in this case shall be indicated,
(c) the name of the product to be used in the treatment programme, including indication of the content of the active substances and whether the 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 product used to the extent appropriate to the pharmaceutical data submitted with the application for authorisation or with the notification of a clinical trial under a specific legislation; (2) in the case of products registered abroad, such data may be replaced by a certificate of release of each batch of the product used in the manufacturer's country; in the case of products registered in a Member State of the European Union or, where applicable, the European Economic Area, pharmaceutical data shall not be submitted if the summary of the product characteristics referred to in point (e) is contained in the draft treatment programme;
(e) preclinical and clinical data to the extent appropriate to the investigator's file submitted in the application for authorisation of a clinical trial; (3) in the case of products authorised abroad, such data may be replaced by a Czech text of a summary of product characteristics or other summary information for health professionals approved by the competent authority of the country in which the product is authorised;
4)
(g) identification data (1) of the person responsible for distribution of the product;
(h) information for a patient in the Czech language appropriate to the information to be provided to the designated clinical trial subjects and, where appropriate, to the package leaflet of the medicinal product,
(i) identification data (1) 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;
(j) whether the initiation of the treatment programme is considered urgent;
(k) where applicable, proof of the cost reimbursement of the examination of the application (Section 65 (2) of the Act).
(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 its 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 (Section 31a (2) of the Act). The outcome of the assessment shall be communicated by the Ministry of Health to the applicant and to the institute which, in case of consent, shall assign a code to the product if it is 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 product, its pharmaceutical form, the qualitative and quantitative content of the active substances in the product, the size and number of packages;
(b) the name, surname and place of residence of the applicant, if any, if any, the natural person or, where applicable, the business name and registered office, if any, the legal person;
(c) the objective of the programme and the duration of the consent.
Footnotes 1) to 3) shall be renumbered as footnotes 5) to 7), including the footnotes references.
1) Sections 19 to 19b of the Civil Code. Section 8 to 12 of the Commercial Code.
2) Annex No 6 to Decree No. 472 / 2000 Coll., laying down good clinical practice and detailed conditions for clinical trial of medicinal products.
3) Annex No 5 to Decree No 472 / 2000 Coll.
4) Annex No 1 to Decree No 472 / 2000 Coll. '.
5. In Paragraph 3 (1), the words "the State Institute for Drug Control (hereinafter referred to as the Institute ')' are replaced by the words" the Institute '.
6. In Article 3, at the beginning of paragraph 2, the words "other than those laid down by law 'shall be inserted after the words" In the application'.
7. in Article 3 (2), points (a) and (c) are deleted and in point (b), the words "first name, last name" are replaced by the words "first name and, where appropriate, first name."
Points (b), (d) and (e) shall become points (a), (b) and (c).
8. In Paragraph 3 (4), the word "certificate 'is replaced by" document' and the words "and proof of reimbursement of costs of the examination of the application 'are added after the word" fee'.
9. In the second sentence of Article 3 (5), the part of the sentence behind the semicolon, including the semicolon, is deleted.
10. In Article 3, the following paragraphs 6 to 9 are inserted after paragraph 5:
"(6) In the case referred to in Article 26 (1) of the Act, such applications for registration or applications for amendment shall be considered as justified in the labelling of the medicinal product in which the applicant expresses an interest in putting the information on the packaging in a non-Czech language; and
(a) the product is intended for the treatment of severe diseases and for use in the provision of medical care under the supervision of a physician, including the treatment of a patient and outside a healthcare facility;
(b) the frequency of the disease may be inferred that the number of packages put into circulation shall not exceed 2000 units per year;
(c) the design of the label on the outer packaging shall be submitted in English, German or Slovak; and
(d) the equivalent product is not registered and put into circulation with the packaging indicated in the Czech language.
(7) The fact referred to in paragraph 6 (b) shall be documented in the case of registration applications with a balance sheet for anticipated annual consumption, in the case of registered products, by consumption over the previous years. In the event of subsequent higher consumption of the product than 2000 units per year, the marketing authorisation holder shall submit an application for a change in the label on the packaging not related to a change in the summary of product characteristics according to Section 26c (7) of the Act.
(8) In justified cases, the Institute may, upon request, allow the individual batches of the medicinal product to be put into circulation even if the particulars on the packaging are in a non-Czech language. This can only be allowed if the following conditions are met:
(a) is a medicinal product the issue of which is subject to medical prescription by a marketing authorisation decision;
(b) unless an equivalent product is registered and put into circulation with a packaging in the Czech language,
(c) the number of packages of the batch of the medicinal product corresponds to the need to address the immediate shortage of the medicinal product, the label of which is in the Czech language, to the extent necessary;
(d) the availability of the product would have immediate serious consequences for public health;
(e) the lot of the product has been placed on the market in the State of the European Union,
(f) the labelling is made in Latin, and the essential particulars, in particular the name of the medicinal product, strength, pharmaceutical form, active substance, the holder of the marketing authorisation, the storage method and the shelf life, correspond to the conditions of the marketing authorisation in the Czech Republic and can be derived from the text in a foreign language,
(g) each package leaflet is accompanied by an approved package leaflet in the Czech language, supplied together with each single package. If, in exceptional cases, this information is not included in the outer packaging, it must be attached externally or it must otherwise be ensured that the patient receives the relevant information,
(h) on the outer packaging or, where appropriate, on the inner packaging, if the outer packaging does not exist, the UN code and the registration number of the product in the Czech Republic are supplemented by an appropriate means, in particular by means of printing or sticker; and
(i) the graphic presentation covers similar packaging treatments marketed in the Czech Republic.
(9) Compliance with the conditions referred to in paragraph 8 shall be demonstrated by the applicant in the application and its annexes. ';
Paragraph 6 shall become paragraph 10.
11.
Types of applications for marketing authorisation
The following types of applications shall be submitted in the context of the registration procedure:
(a) an application which is supported by documentation in the full scope of the requirements of Section 24 (5) of the Act and Annexes No 1 to 4 to this Decree, 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 the basis of a separate application or, where a further application for registration is requested, if a change is requested pursuant to Section 6 (5), significantly changing the existing marketing authorisation of the product 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 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 procedure by another marketing authorisation holder, provided that the products are essentially similar (§ 1 (c)), in accordance with § 24 (6) (a) or (c) and § 7 of the Act ("the application with reference"); in the case of the use of the provisions of § 24 (6) (c) of the Act, the period of six years must expire at the latest by the date of the 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, this application may not be made if it is for human products, for laying hens or for those products in which
1. the basic tincture is higher than 1: 10 000 dilution,
2. the basic substances are higher than 1: 100 000 dilution; or
3. the active substance is greater than one hundredth of the smallest therapeutic dose. '
12. in Article 5 (1) to (5):
"(1) 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. However, where, in the case of a human product, the breakdown of the complete European Common Technical Document is used, the requirements set out in Annex 1A. Human preparations for the breakdown of the complete registration dossier are satisfied. The scope of the dossier submitted with the application corresponds to the knowledge of the product, its nature, the therapeutic 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.
(2) The individual application is supported by the full documentation set out in Annex 1 to this Decree. In the case of a literary application, the rules set out in Annex 1A shall apply when demonstrating a well-established therapeutic use. Human preparations of Part III (k) and Part IV (1) (d), or of Annex 1 (B). Veterinary preparations (3). The relevant technical literature shall be submitted.
(3) Parts III and IV of the dossier and the relevant expert reports referred to in Annex 1 to this Decree shall not be submitted with a reference. Furthermore, the documentation necessary for the assessment of the safety and efficacy aspects of the product, which are not included in the dossier referred to, shall be provided if necessary; the essential similarity of the product for which registration is sought with respect to the product referred to should be demonstrated, for example, by evidence of bioequivalence or pharmacodynamic or therapeutic equivalence. In the case of applications with reference to the proposed Summary of Product Characteristics, it shall correspond 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. In the case of a request submitted with the consent of the original holder [Paragraph 24 (6) (a) of the Act], such consent shall be supported.
(4) The application for simplified registration of a medicinal product for human use shall not be submitted in accordance with Part A of Annex 1 to this Regulation, the relevant expert report and the draft summary of product characteristics.
(5) The application for a simplified registration of a veterinary homeopathic product shall be submitted in accordance with Annex 1 (B) (4) to this Regulation; no expert reports and a draft SPC shall be submitted on the application for simplified registration of veterinary homeopathic products. ';
13. In Article 5, the following paragraphs 6 and 7 are inserted after paragraph 5:
"(6) In accordance with § 26e (3) of the Act, the
(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 preparations if their recommended daily dose does not contain more than 3333 units of vitamin or more than 400 units of vitamin D; such preparations may include minerals,
(c) adsorption anti-diarrhoeic agents containing activated charcoal, provided that each pack contains not more than 20 units of the formulation,
(d) antiemetics containing theoclan moxastinium at a maximum of 25 milligrams per unit of formulation and if each pack contains a maximum of 20 units of formulation,
(e) preparations containing paracetamol in a maximum quantity of 500 milligrams per unit of formulation and if each pack contains not more than 12 units of the formulation,
(f) preparations containing ibuprofen in a maximum quantity of 200 milligrams per unit of pharmaceutical form, and if each pack contains a maximum of 20 units of pharmaceutical form,
(g) preparations intended for surface disinfection of minor skin injuries and disinsectisation preparations intended for external use;
(h) medicinal products in the form of patches containing local-acting derivative active substances;
(i) preparations in the form of patches or chewing gum containing nicotine for smoking cessation.
(7) The indication of the symbol ® as a mark is an indication whose legitimacy is not verified by the Constitution or the Veterinary Institute. When assessing the interchangeability of names pursuant to § 25 (7) (a) (6) of the Act, account shall be taken in particular of whether the name in the printed, manuscript or pronounced form is not interchangeable with the name of another product. The assessment shall take into account the likelihood of confusion in the normal treatment of the product and the consequences of possible confusion on patients' health.
Paragraphs 6 and 7 shall be renumbered paragraphs 8 and 9.
14. in Paragraph 5 (8), the words "paragraph 4 or paragraph 5" shall be replaced by the words "paragraph 2 or paragraph 3";
15. in Article 6 (1) (a), "§ 27 (1)" is replaced by "§ 26a (2)."
16. In Article 6, at the end of paragraph 2, the sentence "All proposed amendments shall be indicated in these proposals in relation to the original text."
17. in Article 6 (5), at the end of point (j), the dot is replaced by a comma and the following points (k) and (l) are added:
'(k) the addition or modification of the target species, if applicable,
(l) shortening the withdrawal period if the veterinary medicinal product is intended for administration to food-producing animals. "
18. In Article 6, the following paragraph 7 is added:
"(7) 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 referred to in Article 26c (7) of the Act, the justification for the change and the proposals for labelling or package leaflet shall be provided together with the notification of such change. ';
19. After Paragraph 6, the following Sections 6a and 6b are inserted:
Following the application of the procedure under § 27a (1) to (3) of the Act, the conditions for registration of the product in the Czech Republic and the Member States of the European Union shall be maintained as follows:
(a) in the case of an urgent safety restriction carried out in the Member States of the European Union, the marketing authorisation holder shall immediately inform the Institute or Veterinary Institute and proceed in accordance with Section 26a (4) of the Act;
(b) in the event of a change to the marketing authorisation made in the Member States of the European Union, the marketing authorisation holder shall submit an application for an amendment to the marketing authorisation of the institute or veterinary institute in the same manner and with the same documentation no later than 30 days after the completion of the mutual recognition procedure in the Member States of the European Union;
(c) in the event of suspension, revocation or non-renewal of a marketing authorisation in the Member States of the European Union, the marketing authorisation holder shall immediately inform the Institute or the veterinary institute and inform the reasons for which the marketing authorisation has been suspended, revoked or renewed.
Transfer of registration
The application for a marketing authorisation to another legal or natural person submitted by the marketing authorisation holder shall, in addition to the formalities required by law, contain in particular the following information 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 and surname and address of the existing marketing authorisation holder and the name and address of the person to whom the decision is to be transferred, the draft 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 that dossier, has been made available or transferred to the person to whom the decision is to be transferred, corresponding to the documentation submitted to the institute or veterinary institute in the context of the registration procedure or, where appropriate, to the procedure for amending the marketing authorisation,
(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, address and contact details 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 information service on medicinal products referred to in Article 26 (9) (g) (1) of the Act, including contact details;
(e) the draft summary of product characteristics, the labelling and the package leaflet indicating the name or name of the person to whom the decision is to be transferred, which, in addition to administrative data, shall be identical to the approved summary of product characteristics, the labelling and the package leaflet of the product concerned. ";
20. In Article 7, paragraphs 3 to 6 are added:
"(3) Where, with regard to certain therapeutic indications, the registrant of a medicinal product for human use can demonstrate that he is unable to provide complete data on quality, efficacy and safety under normal conditions of use because:
(a) the indications for which the product is intended occur so rarely that the applicant cannot be reasonably expected to provide complete evidence;
(b) in the current state of scientific knowledge, complete information cannot be provided; or
(c) the collection of such information would be contrary to the general principles of medical ethics adopted.
(4) Registration under paragraph 3 may be granted on condition that:
(a) the applicant terminates, within a time limit specified by the Institute, a programme of studies which may consist of further clinical evaluation or a specific plan for early identification and minimisation of potential risks and the results of which will form a basis for reassessment of the benefit / risk profile;
(b) the product may be issued only on medical prescription and may, in certain cases, be administered only under medical supervision or, where appropriate, in a health care institution, and in radiopharmaceuticals by an authorised person; and
(c) the package leaflet and any medical information will draw your doctor's attention to the fact that the data available for the product are insufficient in certain specified respects.
(5) The Institute or Veterinary Institute shall assess the data submitted in the context of the fulfilment of the conditions referred to in paragraph 4 and, on the basis of that assessment, reassess whether the benefit of the use of the product continues to exceed the risks associated with its use under conditions defined by the Summary of Product Characteristics.
(6) 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) 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 subject to specific obligations in accordance with Section 26 (6) (a) of the Act.
21. in Paragraph 8 (d):
"(d) the periodic safety update report referred to in Article 9 so that, following the reports already submitted (Article 52b (6) of the Act), the whole period from the granting of the marketing authorisation or the last renewal of the marketing authorisation, if it is a medicinal product for human use, or in accordance with the veterinary institute's instructions, if it is a veterinary medicinal product. If this period is covered by more periodic updates of the safety reports, the institute or veterinary institute may further require the submission of a bridging summary report for that period, '.
22.
Periodic safety update of the medicinal product
(1) The periodically updated safety reports for a medicinal product referred to in Section 52b (6) of the Act submitted to the Institute have the content and breakdown set out in Annex 7 to this Decree.
(2) The bridging summary report shall cover the period described in several reports referred to in paragraph 1. This report shall have content and breakdown as referred to in paragraph 1.
(3) The reports referred to in paragraphs 1 and 2 shall be submitted to the Institute within 60 days of the end of the period which they cover.
(4) The reports referred to in paragraphs 1 and 2 may be submitted in electronic form. "
23. The following Section 9a is inserted after Section 9, including the title:
Notification of undesirable effects to the human product
(1) The notification of suspected or adverse effects by persons who are required to submit such notification under the law shall include in particular:
(a) particulars of the person being treated, including initials, date of birth, age and sex, sufficient for communication of at least one of those particulars;
(b) identification data (1) of the notifier,
(c) a description of the adverse event;
(d) the name of the medicinal product or active substance administered to the person being treated, or any other information enabling it to be identified, the dose administered and the route of administration.
(2) A form published by the Institute in its information medium is used for notification; However, notification may also be made in another demonstrable way, provided that it contains the information referred to in paragraph 1.
(3) Notification of adverse effects of medicinal products for human use, including additional information provided for the proper evaluation of individual cases, is provided in an anonymous form in relation to the person being treated. The data referred to in point (a) of paragraph 1 shall be communicated to the treated person, on the basis of which only the notifying person (e.g. year of birth and initials) can identify the treated person. Information received to identify the person being treated directly (1) shall not be processed and shall not be retained on data media.
(4) Where notification of a suspected serious adverse event consists in the provision of information drawn from professional literature or electronic sources of information, the provisions of paragraph 1 shall not apply and only the indication of the source of information is sufficient.
(5) The notified suspected serious adverse reactions are transmitted by the Institute to the Marketing Authorisation Holder (Section 52c (2) of the Act) without identifying the person who made the notification.
(6) The addition of information to the notification of adverse reactions shall be ensured by the institute or the marketing authorisation holder, whichever of them has received the first notification. In the event of a time-limit for receipt of the report, it shall do so by mutual agreement.
(7) The obligation under Article 52c (2) of the Act may also be exercised by means of a computer network set up by the Agency pursuant to Article 52c (1) of the Act. The receipt of a confirmatory report through that computer network of notification to the marketing authorisation holder shall be deemed to have fulfilled this obligation. ';
24. In Annex 1 (A) to Part I (1) (d) (1) and (2):
"1. the product is authorised, including the year of registration and the registered name; where the product is authorised in a Member State of the European Union, the legal basis for the marketing authorisation and the type of procedure which the marketing authorisation has been granted shall be indicated;
2. the registration is applied for or where the application for a marketing authorisation has been withdrawn or the marketing authorisation refused, including a statement of reasons; where registration is applied for in a Member State of the European Union, the legal basis for registration and the type of procedure applied for shall be indicated. ';
25. The sentence "In the case of an application for registration of a radionuclide generator, the general description of the system shall be given together with a detailed description of the components of the system which may affect the composition or quality of the product with a subsidiary radionuclide, as well as qualitative and quantitative data on the eluate or sublimate."
26. In Annex No 1 A. Human preparations of Part IIC - Control of starting materials, at the end of the second paragraph, the sentence "If such data are not submitted to the Institute with an application, this application shall not be considered complete."
27. in Annex No 1 A. The following point (k) is added at the end of Part III:
"(k) Good established therapeutic use
In order to demonstrate that the component (s) of the product have a well established therapeutic use with an acceptable level of safety pursuant to Section 24 (6) (b) of the Act, the following specific rules shall apply:
1. The factors to be taken into account in the determination of the "well-established therapeutic use" of the constituents of the preparation are the time during which the substance is used, the quantitative aspects of the use of the substance, the degree of scientific interest in the use of the substance (reported in the published scientific literature) and the consistency of scientific evaluations. Different time periods may be necessary to determine the "well-established therapeutic use 'of different substances. However, in any case, the period required for the determination of the" well-established therapeutic use' of the ingredient is not less than 10 years after the first systematic and documented use of the substance in the preparation in the Czech Republic or in the Member States of the European Union.
2. The documentation submitted by the applicant shall support all aspects of the safety assessment and shall include or refer to an overview of the relevant literature, taking into account pre-marketing and post-marketing studies and published scientific literature on experience in the form of epidemiological studies, in particular comparative epidemiological studies. All documentation shall be submitted both favourable and unfavourable.
3. Particular attention shall be paid to any missing information and shall be given to why proof of an acceptable level of safety may be confirmed, even if some studies are missing.
4. The expert report explains the seriousness of all submitted data concerning a product different from that to be placed on the market. It shall be considered whether the product under consideration can be considered to be similar to the product to which registration is to be granted, despite existing differences.
5. Experience with other products containing the same post-market ingredients is of particular importance and will be taken into account by the applicants in the documentation submitted. '
28. In Annex 1A. The following point (d) is added at the end of Part IV:
"(d) A well established therapeutic use
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Regulation Information
| Citation | Decree No. 302 / 2003 Coll., amending Decree No. 473 / 2000 Coll., laying down the details of the marketing authorisation, its amendments, extensions, the method of dispensing the medicinal product, the method of notification and evaluation of the adverse effects of the medicinal product and the manner and extent of notification of the use of the non-authorised medicinal product |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 18.09.2003 |
|---|---|
| Effective from | 01.10.2003 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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