Decree No. 256 / 2003 Coll.
Decree amending Decree No. 296 / 2000 Coll., laying down good manufacturing practice, good distribution practice and closer conditions for authorising the manufacture and distribution of medicinal products, including medicated feed and veterinary autovaccines, amendments to the permits issued, and further conditions for issuing authorisations for the operation of control laboratories
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Order
Effective from 01.09.2003
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256
DECLARATION
of 29 July 2003
amending Decree No. 296 / 2000 Coll., laying down good manufacturing practice, good distribution practice and closer conditions for authorising the manufacture and distribution of medicinal products, including medicated feed and veterinary autovaccines, amendments to the authorisations issued, and further conditions for authorising the operation of control laboratories
The Ministry of Health and the Ministry of Agriculture provides pursuant to § 75 (2) (a) of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws, as amended by Act No. 149 / 2000 Coll. and Act No. 129 / 2003 Coll., (hereinafter "the Act '):
Decree No. 296 / 2000 Coll., establishing good manufacturing practice, good distribution practice and closer conditions for the authorisation of the manufacture and distribution of medicinal products, including medicated feed and veterinary autovaccines, amendments to the authorisations issued, as well as further conditions for the issue of authorisations for the operation of control laboratories, are amended as follows:
1.
(1) According to this decree,
(a) the production, distribution and quality control of medicinal products and medicinal substances;
(b) imports of medicinal products and active substances from third countries; and
(c) control of the activities referred to in points (a) and (b).
(2) The Order lays down the particulars of the application for
(a) authorisation of manufacture of medicinal products, or amendment of authorisation of manufacture of medicinal products;
(b) authorisation for imports of medicinal products from third countries; and
(c) the authorisation of the distribution of medicinal products or the modification of the authorisation of the distribution of medicinal products, including medicated feed and veterinary autogenic vaccines.
(3) Furthermore, the Decree lays down detailed conditions for authorising the operation of control laboratories.
2. in Article 2, point (h) is deleted;
Point (i) shall be renumbered as point (h).
3. in Article 3 (1), point (b) is deleted;
Points (c) to (f) shall be renumbered (b) to (e).
4. Paragraph 3 (2) is deleted.
Paragraphs 3 and 4 shall become paragraphs 2 and 3.
5. In Paragraph 3 (2), the words "in particular management staff 'are replaced by the words" staff of departments involved in the quality assurance system'.
6. Paragraph 4 (1) reads as follows:
"(1) The number of eligible workers (5) and the requirements for their qualification shall be determined in such a way as to correspond to the type and extent of medicinal products manufactured and to the quality assurance needs at each manufacturing site."
7.
Quality control
(1) The quality control unit [§ 41b (c) of the Act] has one or more laboratories, which are equipped with a sufficient number of eligible staff and facilities for laboratory control of starting materials, packaging materials, intermediate products and final products.
(2) Individual quality control activities, including validation of procedures, shall be carried out according to pre-established specifications, standard operational procedures, documentation submitted under the marketing authorisation procedure (3) and manufacturing authorities.7)
(3) When checking the quality of the batch of the medicinal product before its release into distribution, the evaluation shall be carried out on:
(a) the results of quality checks prescribed for the manufactured medicinal product;
(b) details of the production conditions, including the results of the checks during the production process;
(c) the results of the checks carried out on the documentation of the own manufacture of the medicinal product;
(d) the appearance of the packaging of the final product;
(e) the conformity of the controlled data referred to in points (a) to (d) with the medicinal product registration dossier data.
For medicinal products not manufactured in batches, quality control shall be evaluated in accordance with points (a) to (d) before their release for distribution or supply.
(4) Each batch of the medicinal product shall be sampled; these samples shall be kept for at least 1 year after the expiry date of the lot of the medicinal product from which they were taken.
(5) From materials intended for the manufacture of medicinal products, except solvents, gases or water, samples shall be kept for at least 2 years after the release of the manufactured batch of medicinal products; that period may be shortened if the stability of the starting substance specified in its specification is shorter.
(6) The samples referred to in paragraphs 4 and 5 shall be kept for any use by the State Institute for the Control of Medicinal Products, if any, if it is for a medicinal product for human use or the Institute for State Control of Veterinary Bioprafts and Medicines, if it is for a veterinary medicinal product. In the case of medicaments manufactured individually or those which are difficult to store, conditions of storage and sampling different from those laid down in paragraphs 4 and 5 may be established following prior consultation with the manufacturer and with the State Institute for the Control of Veterinary Bioprafts and Medicines.
(7) The provisions of paragraphs 4, 5 and 6 do not apply to transfusion preparations and raw materials or intermediate products of blood and its constituents for further production. "
8. In the first sentence of Article 9 (1), the words "or the control laboratory 'shall be inserted after the words" the external manufacturer of medicines'.
9. In Article 9 (2), the words "including an external control laboratory 'are replaced by the words" or a control laboratory';
(10) Paragraph 10 (2), including footnote 10, shall be deleted and the designation of paragraph 1 shall be deleted.
11.
Good manufacturing practice means requirements for the production of blood transfusions and raw materials or components thereof, in particular the production of blood and its components, their processing, labelling, control, storage, packaging, transport, delivery and documentation in these activities. Good manufacturing practice in a transfusion service facility also means requirements for the intake, storage and supply of blood products and blood derivatives. Unless otherwise provided for in Section 2, the transfusion service shall proceed under the conditions of good manufacturing practice set out in Section 1. ';
12. In Article 15 (9), the words "including its ongoing registration and any derogations from those storage conditions' are replaced by the words" including the continuous registration of the storage conditions achieved. ';
13. Article 17 (1) in the introductory phrase, the words "within the scope of its production authorisation" shall be deleted.
14. in Article 17 (1) (b), the words "in accordance with its production authorisation" shall be deleted;
15. in Article 17 (5), the word "recipient" shall be replaced by "customer."
16. Paragraph 17 (6), including footnote 14a, reads:
"(6) The authorisation to issue 14a) blood products and blood derivatives is granted in writing by the head of the establishment of the blood services.
14a) § 48 (3) (e) of the Act. '
17. in Article 19 (1), the words "the customer" shall be inserted after the words "the information";
18. After Section 2, the following sections 3 and 4 are inserted:
CONTROL LABORATORY
The rules of good manufacturing practice shall be established for the control laboratory as follows:
(a) The control laboratory shall comply with the provisions of Sections 3 to 6, 8 and 9 mutatis mutandis.
(b) The control laboratory shall issue to the manufacturer a verification of the quality of the active substance or of the excipients supplied to persons authorised to prepare medicinal products a document containing at least the following particulars:
1. the name of the substance,
2. reference to the test standard (s),
3. the lot number,
4. Shelf life,
5. an indication of the representativeness of the sample used for testing,
6. range of testing, including test limits;
7. results of individual tests,
8. end of test,
9. Date of issue of the document,
10. identification number of the quality verification document, including the control laboratory registration number.
PRODUCTION OF ACTIVE SUBSTANCES
(1) Unless otherwise provided for in this Section, the manufacture and control of active substances shall be carried out in accordance with the conditions of good manufacturing practice set out in Section 1.
(2) The manufacturer of active substances producing the gases used in the provision of health care shall provide any supply of gas to the health establishment with evidence of quality verification.
(3) The manufacturer of active substances supplied to persons authorised to prepare medicinal products shall issue proof of the quality verification of the active substance or of the excipients containing the particulars referred to in Article 20a (2) and, where appropriate, shall ensure that such evidence is produced. ';
Sections 3 to 5 to date shall be renumbered Sections 5 to 7.
19. Section 5, including the title, reads:
PRODUCTION OF MEDIUM-BASED FEED
Unless otherwise provided in this Section, the production and control of medicated feed shall be carried out under the conditions of good manufacturing practice set out in Section 1.
Specific principles of good manufacturing practice of medicated feed
(1) The manufacturer of medicated feed collects medicated premixtures for the manufacture of medicated feed only from medicated feed producers or distributors.
(2) The quality control carried out by the manufacturer of medicated feed shall include, in particular, regular checks on homogeneity, stability, storage of manufactured medicated feed and cross-contamination, including laboratory verification.
(3) The samples taken from each batch of medicated feed shall be kept for at least 5 months after the expiry date of that lot.
(4) The documentation and records referred to in Article 6 shall also include the rules for medicated feed producers, records of the type and quantity of medicated premixtures and feedingstuffs used for the manufacture of medicated feed, the addresses of the animals referred to in the prescription for medicated feed, the identification of the distributor, unless the distribution of the medicated feed itself is provided by the manufacturer, and the identification of the veterinarian who prescribed the manufacture of the medicated feed.
(5) Medicated premixtures, medicated feed intermediates and medicated feed are stored in appropriate separate and secure premises or hermetically sealed containers for storage of those products.
(6) Medicated feedingstuffs are always labelled "medicated feed." In addition, the packaging of medicated feed or as part of the accompanying documentation of medicated feed (Section 41k (10) of the Act) shall include:
(a) the manufacturer of medicated feed;
(b) medicated premix used for the manufacture of medicated feed;
(c) the active substance contained in medicated feed, indicating the name and concentration;
(d) batch number of medicated feed;
(e) the species and category of animals for which medicated feed is intended,
(f) specific instructions for breeders, in particular the quantity of medicated feed in the daily ration, frequency of administration, duration of treatment, withdrawal period,
(g) the date of application of the medicated feed;
(h) storage conditions,
(i) the method of handling unused medicated feed;
(j) the entry "For animal treatment only,"
(k) the address of the breeder for which the medicated feed is intended.
(7) The model of the designation shall be indicated by the Institute for State Control of Veterinary Bioprafts and Medicines in its information medium.
(1) The qualified person of the manufacturer of medicated feedingstuffs (Section 41j (12) of the Act) undergoes a specialised course (Section 41j (11) of the Act) which includes teaching the following subjects:
(a) legislation of the Czech Republic and the European Community on the regulation of medicinal products, including medicated feedingstuffs, and feedingstuffs;
(b) pharmacology,
(c) toxicology;
(d) technologies for the production of medicated feed and feed, with a particular focus on homogeneity, stability and preservation of medicated feed and on contamination and cleaning.
(2) The duration of the specialised course is at least 160 hours. The organisation of the specialised course shall be coordinated by the Institute for State Control of Veterinary Bioprafts and Drugs, which shall specify in its information medium the requirements for the course. The Institute for State Control of Veterinary Bioprafts and Drugs shall carry out evaluation of the course proposals and issue opinions on the course proposals with a view to ensuring their expertise.
(3) The evidence of completion of the course shall be provided by the manufacturer of medicated feed in the context of an application for authorisation of production (§ 31) or in the context of an application for a change in the production permit, unless the Institute for State Control of Veterinary Bioprafts and Medicines provides otherwise.
(4) A qualified person shall not release medicated feed into circulation unless the medicated feed has been manufactured, controlled and labelled in accordance with the requirements laid down by the law, its implementing legislation, the conditions laid down in the manufacturing authorisation, the requirements laid down in the specific instructions [Paragraph 12 (2) (e) of the Act] or the requirements laid down in the Regulation for medicated feed issued by the competent treating veterinarian.
(3) The manufacturer of medicated feed shall be entitled to negotiate part of the production or control of medicated feed with another manufacturer of medicated feed or, in the case of a control laboratory, under the conditions laid down in Section 9. ';
20. the following Section 6 is inserted after Section 5:
PRODUCTION OF VETERINARY AUTOGENE VACTS
Unless otherwise provided for in this Section, the production and control of veterinary autogenic vaccines shall be carried out under the conditions of good manufacturing practice set out in Section 1.
(1) For the production of veterinary autogenic vaccines, with the exception of viral pathogens or antigens obtained pursuant to Section 41h of the Act, only those raw materials which comply with the quality requirements laid down in the European Pharmacopoeia, the Czech Pharmacopoeia [§ 7 (d) and (e) of the Act] or the pharmacopoeia used officially in the Member States of the European Community or the quality requirements laid down in the specific guidelines of the Institute for State Control of Veterinary Bioprafts and Medicines shall be used.
(2) Viral antigens or viral pathogens, veterinary autogenic vaccines containing live antigens or pathogens and veterinary autogenic vaccines intended for administration to equidae and poultry are not used for the production of veterinary autogenic vaccines.
(3) Prior to the start of the production of each batch of veterinary autogenic vaccine, the manufacturer of autogenic vaccines shall give a notification of the start of production of the Institute for State Control of Veterinary Bioprafts and Drugs and the Regional Veterinary Administration within whose jurisdiction the vaccine will be used. The notification shall include:
(a) the manufacturer of the veterinary autogenic vaccine;
(b) the composition of the veterinary autogenic vaccine (indication of the antigens or pathogens contained in the veterinary autogenic vaccine);
(c) the indication of the stables and the location where the antigens or pathogens used for the production of the veterinary autogenic vaccine have been obtained and where the veterinary autogenic vaccine will be used;
(d) the species and category of animals in which the veterinary autogenic vaccine will be used;
(e) the name and permanent residence of the veterinarian who prescribed the veterinary autogenic vaccine;
(f) the total prescribed amount of the veterinary autogenic vaccine,
(g) the indication of the stables and the location where the veterinary autogenic vaccine will be used;
(h) the date of application of the veterinary autogenic vaccine;
(i) special warnings if they are provided in the veterinary prescription for the production of the veterinary autogenic vaccine (Section 41h (2) of the Act).
(4) The manufacturer of the veterinary autogenic vaccines shall take such measures as to ensure that the internal and, if present, the outer packaging of the veterinary autogenic vaccines is accompanied by the following information:
(a) the manufacturer of the veterinary autogenic vaccine;
(b) the batch number of the veterinary autogenic vaccine,
(c) the date of application of the veterinary autogenic vaccine; the date of application is not more than 6 months from the date of manufacture of the veterinary autogenic vaccine,
(d) a laboratory which has isolated the antigen or pathogens, if different from the manufacturer;
(e) the composition of the veterinary autogenic vaccine;
(f) the name and permanent residence of the veterinarian who prescribed the veterinary autogenic vaccine;
(g) indication,
(h) the species and category of animals in which the veterinary autogenic vaccine is to be used;
(i) the breeding and locality from which the antigens or pathogens used for the production of the veterinary autogenic vaccine have been obtained;
(j) a warning that the vaccine can only be used in the herd and in the site where the antigens or pathogens from which the veterinary autogenic vaccine was manufactured, with a specific indication of the site;
(k) a warning that the vaccine may only be used by the treating veterinarian who prescribed the veterinary vaccine, indicating the name and permanent residence of the veterinary surgeon concerned,
(l) the warning "Veterinary autogenic vaccine - must be tested for tolerability in target animals before use!"
(m) storage conditions,
(n) the entry "For animal treatment only,"
(o) special warnings if they are provided in the veterinary prescription for the production of the veterinary autogenic vaccine (Section 41h (2) of the Act),
(p) an alert for the treatment of unused or unused autogenic vaccine (§ 41h (2) of the Act).
(5) The manufacturer shall document, in accordance with Section 6, the treatment of antigens or pathogens used for the production and evaluation of veterinary autogenic vaccines. The documentation and records referred to in § 6 also include rules for the production of veterinary autogenic vaccines for manufacturers of veterinary autogenic vaccines.
(6) In the context of quality control, manufacturers of veterinary autogenic vaccines shall take measures to ensure, in particular, the microbiological quality of veterinary autogenic vaccines in accordance with the microbiological quality requirements for veterinary immunological medicinal products laid down in the European Pharmacopoeia [§ 7 (d) of the Act] and the tolerance test on target animals. '
Sections 6 and 7 shall be renumbered Sections 7 and 8.
21. in Article 24 (1) (d), including footnotes 19a and 19b:
"(d) pharmaceuticals which do not have an extended shelf life and are packed in intact original packaging only from the supplier who is entitled to this activity, 18) or from the foreign manufacturer or distributor of the medicinal products who is entitled to such activities. In the case of medicinal products only those which have been registered, 19) or non-registered human 19a) or for specific treatment programmes, 19b)
19a) § 5a (3) of the Act.
19b) § 31a of the Act. '
22. in Paragraph 24 (1) at the end of point (g), the comma is replaced by a dot and point (h) is deleted;
23. Paragraph 24 (2) is deleted.
Paragraph 3 shall become paragraph 2.
24. in Paragraph 27 (3), "Article 24 (f)" is replaced by "Article 24 (1) (g)";
25. in Article 27 (4), point (d), including footnote 22, shall be deleted;
Points (e) and (f) shall be renumbered as points (d) and (e).
26. In Paragraph 27, the following paragraph 5 is inserted after paragraph 4:
"(5) Records of the distribution of advertising samples of medicinal products shall be governed by the provisions of paragraph 4 mutatis mutandis. ';
Paragraphs 5 and 6 shall become paragraphs 6 and 7.
27. in § 27 (7) (a), the words "decision to grant an exemption from the registration of the Ministry of Health 23)" shall be replaced by the words "written consent of the Ministry of Health to a specific treatment programme."
28. Paragraph 28 (6), including footnote 24a, reads as follows:
"(6) Unregulated medicinal products for human use 19a) or medicinal products for specific therapeutic programmes19b) or active substances not listed in § 75 (2) (f) of the Act and authorised for use by the Ministry of Healthcare 24a) are stored separately from other medicinal products.
24a) § 7 (c) of the Act. '
(29) Paragraph 29 (2), including footnote 10, shall be deleted and the designation of paragraph 1 shall be deleted.
30. The following paragraphs 29a and 29b are inserted after Article 29:
Distribution of active substances and excipients
(1) The provisions of this Section shall apply mutatis mutandis to the distribution of active substances and excipients to persons authorised to prepare medicinal products and to the distribution of blood and its components, where appropriate, of intermediate products produced from blood and its constituents for further production. Sampling, laboratory inspection, disassembly, packaging and labelling shall also be carried out on the basis of a manufacturing permit or a certificate from the manufacturer of the active substances. Sample and laboratory control shall also be carried out on the basis of an authorisation to operate the control laboratory.
(2) The distributor of active substances and excipients supplied to persons authorised to prepare medicinal products will satisfy themselves that a proof of verification of the quality of the active substance or of the excipients has been issued to the active substance or the active substance, which contains the information referred to in Article 20a (2), and will ensure the availability of that document to the customer upon request.
(3) The distributor of active substances and excipients supplied to persons authorised to prepare medicinal products will only supply those substances which are marked on the packaging with the name of the substance, the quality specification of the substance, the batch number, storage conditions, the period of application and the document number of the quality verification of the substance, including the registration number of the control laboratory.
Specific rules for the distribution of medicated feed
(1) Paragraph 24 to 29 shall apply to the distribution of medicated feed, unless otherwise specified.
(2) Distributors who have extended the distribution authorisation to the distribution of medicated feed only take medicated feed from producers who have a valid authorisation to manufacture medicated feed.
(3) Medicated feed shall only be distributed to those persons who, as recipients, are listed in the medicated feed regulation.
(4) The distributor shall not take over for distribution or distribution of medicated feed, the quantity of which exceeds that specified in the medicated feed regulation (Section 41j (2) of the Act).
(5) Only medicated feed properly labelled in original intact packaging shall be distributed; in the case of medicated feed distributed in bulk carriers, these transporters are secured in accordance with the requirements of the law (§ 41k (12)); in these cases, the data to be included on the packaging form part of the documentation for the distribution of medicated feed (Section 41k (9) of the Act).
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Regulation Information
| Citation | Decree No. 256 / 2003 Coll., amending Decree No. 296 / 2000 Coll., laying down good manufacturing practice, good distribution practice and closer conditions for authorising the manufacture and distribution of medicinal products, including medicated feed and veterinary autoaccins, amendments to the authorisations issued, and further conditions for issuing authorisations for the operation of control laboratories |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 12.08.2003 |
|---|---|
| Effective from | 01.09.2003 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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