Decree No. 411 / 2004 Coll.
Ordinance establishing good manufacturing practice, good distribution practice and closer conditions for authorising the production and distribution of medicinal products, including medicated feed and veterinary autogenic vaccines, changes to the authorisations issued, as well as further conditions for issuing authorisations for the operation of control laboratories (Ordinance on the production and distribution of medicinal products)
Valid
Order
Effective from 13.07.2004
Contents
ČÁST PRVNÍ
§ 1
§ 2
ČÁST DRUHÁ
§ 3
§ 4
§ 5
§ 6
§ 7
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
§ 15
ČÁST TŘETÍ
§ 16
§ 17
§ 18
§ 19
§ 20
§ 21
§ 22
§ 23
§ 24
§ 25
§ 26
§ 27
ČÁST PÁTÁ
§ 41
ČÁST ŠESTÁ
§ 42
§ 43
§ 44
ČÁST SEDMÁ
§ 45
§ 46
ČÁST OSMÁ
§ 47
ČÁST DEVÁTÁ
§ 48
§ 49
§ 50
§ 51
§ 52
§ 53
§ 54
ČÁST DESÁTÁ
§ 55
§ 56
§ 57
§ 58
§ 59
ČÁST JEDENÁCTÁ
§ 60
§ 61
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411
DECLARATION
of 21 June 2004
laying down good manufacturing practice, good distribution practice and closer conditions for authorising the production and distribution of medicinal products, including medicated feed and veterinary autogenic vaccines, changes to the authorisations issued, as well as detailed conditions for issuing authorisations for the operation of control laboratories (Ordinance on the production and distribution of medicinal products)
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 '):
INTRODUCTORY PROVISIONS
Subject matter
This decree provides in accordance with the law of the European Community1)
(a) rules on good manufacturing practice and good distribution practice;
(b) the detailed conditions for authorising the manufacture and distribution of medicinal products, including medicated feed and veterinary autogenic vaccines, as well as changes to the authorisations issued;
(c) the detailed conditions for granting authorisations for the operation of control laboratories.
Basic concepts
For the purposes of this decree:
(a) any medicinal product under Article 2 (2) of the Act;
(b) any medicinal product evaluated under Article 33 (3) (d) of the Act,
(c) by the manufacturer, any person carrying out activities for which a permit is required under § 38a (1), § 41 or § 41e (1) and (2) of the Act;
(d) by a qualified person, the person referred to in Article 41b (a) of the Act, if it is a manufacturer of medicinal products, the person referred to in Article 41e (3) (a) of the Act, if it is a transfusion service installation, or the person referred to in Article 42a (1) (b) of the Act, if it is a distributor of medicinal products,
(e) by ensuring quality, a summary of organisational measures taken to ensure the quality required for the intended use of medicinal products and investigational medicinal products; This summary includes rules on good manufacturing practice,
(f) the establishment of the transfusion service by the holder of the authorisation for the production of blood products and raw materials and blood components for further production pursuant to § 41e (1) and (2) of the Act;
(g) a blood bank organizational unit of a health care institution which stores and provides transfusions and conducts pre-transfusion immunohematology tests, exclusively for use in a hospital,
(h) blinding the intended concealment of the identity of the investigational medicinal product as instructed by the contracting authority;
(i) by deleting the identity of the blinded product.
CORRECT PRODUCTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE
General principles
(1) The State Institute for Drug Control (hereinafter referred to as "the Institute"), in carrying out the activities referred to in Articles 9 (1) (e), 38a (3) and 54 (2) (a) to (c) of the Act, is also required to comply with the European Communities' (hereinafter referred to as "the Community") procedures for the inspection and exchange of information2) published by the European Commission (hereinafter referred to as "the Commission").
(2) In interpreting the principles and guidelines for good manufacturing practice, manufacturers and institutes will take into account the detailed guidance issued by the Commission3).
For medicinal products for human use and for investigational medicinal products imported from third countries, the importer shall ensure that such products are manufactured in accordance with standards at least equivalent to the Community standards of good manufacturing practice. Furthermore, importers of medicinal products for human use shall ensure that such products are manufactured by manufacturers authorised for such manufacture. The importer of investigational medicinal products shall ensure that such products are manufactured by a manufacturer notified to the Institute and approved by the Institute for that purpose.
Compliance with the marketing authorisation of medicinal products for human use
(1) The manufacturer shall ensure that all activities in the manufacture of medicinal products for human use which are subject to registration are carried out in accordance with the information submitted in the application for marketing authorisation as approved by the Institute. In the case of investigational medicinal products, the manufacturer shall ensure that all manufacturing activities are carried out in accordance with the information submitted by the contracting authority in the application for authorisation or for the notification of a clinical trial as approved by the Institute.
(2) The manufacturer shall periodically review his manufacturing procedures in the light of scientific and technical progress and the development of the investigational medicinal product. Where it is necessary to make a change in the registration dossier or a change in the documentation submitted in the context of a clinical trial application, the manufacturer of the institute shall submit a request for such change.
Quality assurance system
The manufacturer shall establish and implement an effective quality assurance system involving the active participation of managers and staff of each department.
Staff
(1) At each production site, a sufficient number of eligible and appropriately qualified staff equipped with the necessary powers shall be available to the manufacturer for the activities carried out in order to achieve the quality assurance objective. In compliance with this requirement, account shall be taken, in particular, of the type, extent, professional complexity and the timing of production and control activities.
(2) The obligations of managers and responsible staff, including qualified persons responsible for the establishment and compliance with the rules of good manufacturing practice, shall be laid down by the manufacturer in their workload. Their supervisory and subordinate relationships are determined in an organisational scheme; These schemes and workload shall be approved in accordance with the manufacturer's internal rules.
(3) The manufacturer shall provide his staff with initial and ongoing training and training, the effectiveness of which he shall continuously verify; training and training shall include, in particular, the theory and application of the principles of quality assurance and good manufacturing practice and, where appropriate, specific requirements for the manufacture of investigational medicinal products. Validation means documented verification that production and control processes comply with predetermined parameters.
(4) The manufacturer shall draw up hygiene programmes adapted to the activities to be carried out and verify their compliance on an ongoing basis. These programmes shall in particular include procedures relating to health, hygiene and dressing of workers.
Operating premises and facilities
(1) The manufacturer shall ensure that the premises and production facilities are located, designed, constructed, adapted and maintained in such a way as to satisfy the specific requirements resulting from their use.
(2) The manufacturer shall ensure that the premises and production facilities are distributed, constructed and operated in such a way as to minimise the risk of errors and allow effective cleaning and maintenance to prevent contamination, cross-contamination and any adverse effects on the quality of the medicinal product for human use.
(3) The manufacturer shall ensure that premises and production facilities which are critical to the quality of medicinal products for human use are subject to appropriate qualifications and validation. A documented verification that the premises and facilities are suitable for the intended purpose shall be considered to be qualified. Validation means documented verification that production and control processes comply with predetermined parameters.
Documentation
(1) The manufacturer shall establish and maintain a documentation system based on specifications, manufacturing rules and instructions for processing and packaging, procedures and records for each manufacturing activity carried out. The documents must be clear, without errors and must be updated. The pre-established procedures for general production activities and the conditions, together with the specific documents for each batch, shall be maintained in such a way that they are available. This set of documents shall be established and maintained by the manufacturer in such a way as to enable the monitoring of the production history of each batch and the changes introduced during the development of the investigational medicinal product. In the case of a medicinal product for human use, the batch documentation shall be kept at least 1 year after the date of expiry of the lots to which it relates or at least 5 years after the issue of the certificate referred to in Article 41d (3) of the Act, whichever is the longer. In the case of an investigational medicinal product, the batch documentation shall be kept for at least 5 years after the end or suspension of the last clinical trial in which the batch was used. The contracting authority or the marketing authorisation holder, in the absence of the same person, shall be responsible for keeping the records required for registration under the specific legislature4) if they are required for subsequent registration.
(2) Where electronic, photographic or other data-processing systems are used instead of written documents, the manufacturer shall first validate the systems by demonstrating that the data will be appropriately stored during the expected storage period. Data stored by these systems shall be easily accessible in legible form and shall be provided to the Institute at its request. Electronic storage data shall be protected against loss or damage by methods such as copying or backup or transfer to another storage system. Any interference with the electronically stored data system shall be recorded.
Own production
(1) The manufacturer shall ensure that:
(a) individual manufacturing activities are carried out according to pre-established instructions and procedures and in accordance with good manufacturing practice;
(b) available resources and conditions sufficient to carry out checks during the production process;
(c) all variations in the process and defects of the medicinal product are documented and thoroughly investigated.
(2) The manufacturer shall take technical or organisational measures to prevent cross-contamination and confusion. In the case of investigational medicinal products, the manufacturer shall pay particular attention to the treatment of those medicinal products during and after each blindness.
(3) In the case of medicinal products for human use, the manufacturer shall validate any new manufacturing process or material change in the manufacturing process of the medicinal product. Critical phases of production processes are regularly and repeatedly validated.
(4) In the case of investigational medicinal products, the manufacturer shall validate the manufacturing process as a whole, where appropriate, taking into account the stage of product development. At least critical stages of the process, such as sterilisation, shall be applied. All operations and parts of the design and development of the production process shall be fully documented.
Quality control
(1) The manufacturer shall establish and maintain a quality control system under the authority of the person referred to in Section 41b (b). (c) the law. This person shall have at his disposal one or more quality control laboratories adequately equipped with staff and equipment for carrying out the necessary examinations and tests of the starting materials, packaging materials and tests of intermediate products and final medicinal products for human use, or have access to such laboratories.
(2) In the case of medicinal products for human use, including products imported from third countries, contractual control laboratories authorised under § 41 (2) of the Act may be used, subject to the requirements laid down in § 12. In the case of investigational medicinal products, the contracting authority shall ensure that the contractual control laboratory complies with the content of the application under Section 37 (2) of the Act as approved by the Institute. If the products evaluated are imported from third countries, no analytical check is necessary.
(3) During the final inspection of the final medicinal product for human use before its release for sale or distribution or for use in a clinical trial, the quality control system must take into account, in addition to the analytical results, basic information such as the conditions of production, the results of the checks during the manufacturing process, the examination of the manufacturing documents and the conformity of the medicinal product for human use with its specifications, including the final packaging.
(4) The samples of each batch of the final medicinal product for human use shall be kept by the manufacturer at least 12 months after the expiry date. In the case of an investigational medicinal product, the manufacturer shall keep sufficient samples of each batch of unfilled product and the key packaging components used for each batch of finished product for at least 2 years after the end or suspension of the last clinical trial in which the batch was used, whichever is the longer. Samples of the starting materials used in the manufacturing process, other than solvents, gases or water, shall be kept at least 2 years after release of the product. This period may be shortened if the period of application of the raw materials as specified in the relevant specification is shorter. In order to allow for their follow-up, all such samples shall be kept at the disposal of the competent control authorities. In agreement with the Institute, other conditions of sampling and storage of starting materials and certain preparations which are produced individually or in small quantities or which could cause special problems may be determined.
(5) The qualified person of the manufacturer or, where appropriate, the importer of medicinal products for human use shall release a batch of the investigational medicinal product if:
(a) in the case of investigational medicinal products manufactured in the Czech Republic, they have been manufactured and checked in accordance with the requirements of good manufacturing practice in accordance with § 41b (h) and (i) of the Act, with the data in the product specification folder and with the documentation submitted in the context of the clinical trial application;
(b) in the case of investigational medicinal products imported from a third country, they have been manufactured and checked in accordance with the requirements of good manufacturing practice at least equivalent to those laid down in Community rules, with the data in the product specification folder and with the documentation submitted in the context of the application for a clinical trial;
(c) in the case of an investigational medicinal product which is a comparative product imported from a third country and which is registered in the Czech Republic, it has been subjected to all the necessary analyses, tests and checks necessary to confirm its quality, in accordance with the documentation submitted in the context of a clinical trial application, unless the procedure under Section 41d (2) of the Act can be applied.
(6) Where the release referred to in paragraph 5 takes place in a Member State of the Community, the investigational medicinal products need not be subjected to further checks if they are imported into the Czech Republic from a Member State of the Community and if a batch release certificate signed by a qualified person is available. This provision shall also apply in the case of medicinal products for human use not authorised under a law imported for use by a doctor under Section 5a (3) of the Act from a Member State of the Community or in the case of medicinal products imported for specific treatment programmes under Section 31a of the Act from a Member State of the Community.
(7) In the case of medicinal products not authorised under the law imported for use by a doctor under § 5a (3) of the Third Country Act or in the case of medicinal products imported for specific medical programmes under § 31a of the Third Country Act, the qualified person of the importer under § 41b (a) of the Act shall release a lot of the imported medicinal product provided that he has satisfied himself by all available means that it has been manufactured and checked in accordance with the requirements of good manufacturing practice at least equivalent to those laid down by Community rules; in such cases, analytical control is not required.
Activities under contract
(1) A written contract must be concluded between the contracting authority (the client) and the person to carry out the activity (the recipient of the contract) for each production or production activity carried out under the contract.
(2) The contract referred to in paragraph 1 must clearly define the responsibilities of each party, in particular compliance with good manufacturing practice by the recipient of the contract and the manner in which the qualified person fulfils his obligations.
(3) The beneficiary of the contract may not subcontract any of the works entrusted to him by the contract without the written approval of the client.
(4) The beneficiary of the contract shall comply with the principles and guidelines of good manufacturing practice and shall be subject to checks carried out by the Institute.
Complaints, withdrawal and unblinding of the human medicinal product in urgent cases
(1) In the case of medicinal products for human use, the manufacturer shall establish a system for recording and reviewing complaints together with an effective system which may immediately and at any time be withdrawn from the distribution network of medicinal products for human use. The manufacturer shall record and investigate any complaint concerning a defect of the medicinal product for human use. The manufacturer shall inform the Institute of any defect which could result in withdrawal or unusual restrictions on supply and, where possible, indicate the country of destination. Where medicinal products for human use are subject to registration, withdrawal shall be carried out in accordance with § 53a (4) to (6) of the Act.
(2) In the case of investigational medicinal products, the manufacturer shall, in cooperation with the contracting authority, establish a system for recording and reviewing complaints, together with an effective system for immediately withdrawing investigational medicinal products that have already entered the distribution network. The manufacturer shall record and investigate any complaint relating to the defect of the investigational medicinal product and inform the Institute of any defect which could result in withdrawal or unusual restriction of supply. In the case of investigational medicinal products, all assessment sites shall be identified and, where possible, the country of destination shall also be indicated. In the case of an investigational medicinal product for which a marketing authorisation has been granted, the manufacturer of the investigational medicinal product shall, in cooperation with the sponsor of the marketing authorisation holder, inform the marketing authorisation holder of any defect likely to be related to the authorised medicinal product for human use.
(3) The contracting authority shall establish a procedure for the rapid unblinding of blinded investigational medicinal products when necessary for immediate withdrawal in accordance with paragraph 2. The contracting authority shall ensure that the procedure reveals the identity of the blinded investigational medicinal product only if necessary.
Internal control
The manufacturer shall carry out repeated internal checks as part of a quality assurance system to monitor the implementation and compliance with good manufacturing practice and to enable it to take all necessary corrective measures subsequently. The manufacturer shall keep and keep records of such internal controls and any corrective measures subsequently taken.
Labelling
In the case of an investigational medicinal product, labelling on the packaging shall be such as to ensure the protection of the subject of the evaluation and traceability, to allow identification of the investigational medicinal product and to facilitate the proper use of the investigational medicinal product.
ADMINISTRATIVE PRODUCTION PRACTICE FOR VETERINARY MEDICINAL PRODUCTS
General principles
(1) In carrying out the activities referred to in Articles 12 (1) (e) and 54 (2) (a) to (c) of the Act, the Institute for State Control of Veterinary Bioprafts and Medicines (hereinafter referred to as the "Veterinary Institute") is obliged to comply with the Community procedures for the inspection and exchange of information2) published by the Commission.
(2) In interpreting the principles and guidelines for good manufacturing practice, manufacturers and veterinary institutes will take into account the detailed guidance issued by the Commission (3).
In the case of veterinary medicinal products imported from third countries, the importer shall ensure that such products are manufactured by manufacturers duly authorised to manufacture such products which comply with good manufacturing practice standards which are at least equivalent to those of good manufacturing practice established by the Community.
(1) The manufacturer shall ensure that all manufacturing activities listed in the data and documentation accompanying applications for marketing authorisations for veterinary medicinal products are carried out as they are registered by the veterinary institute or other competent authority in the Community or in a third country.
(2) The manufacturer shall periodically review his production procedures in the light of scientific and technical progress. Where a change to the particulars or documentation on the basis of which the veterinary medicinal product is authorised is required, the manufacturer or the marketing authorisation holder shall submit to the veterinary institute or other competent authority in the Community or in the third country which registers the veterinary medicinal product an application for a change to the marketing authorisation in accordance with the rules applicable to the submission of such applications. If the manufacturer does not hold a marketing authorisation for the veterinary medicinal product concerned at the same time, he shall inform the marketing authorisation holder of the veterinary medicinal product of any circumstances which may lead to the need for a change of marketing authorisation.
Quality assurance system
The manufacturer shall establish and implement an effective quality assurance system involving the active participation of managers and staff of each department.
Staff
(1) At each production site, a sufficient number of eligible and appropriately qualified staff equipped with the necessary powers shall be available to the manufacturer for the activities carried out in order to achieve the quality assurance objective. In compliance with this requirement, account shall be taken, in particular, of the type, extent, professional complexity and the timing of production and control activities.
(2) The obligations of managers and responsible staff, including the qualified person or persons responsible for the establishment and compliance with the rules of good manufacturing practice, shall be laid down by the manufacturer in their workload. Their supervisory and subordinate relationships are set out in the organisational chart; These schemes and workload shall be approved in accordance with the manufacturer's internal rules.
(3) The manufacturer shall provide his staff with initial and ongoing training and training to be undertaken and the effectiveness of which is verified; training and training shall include in particular the theory and application of the principles of quality assurance and good manufacturing practice.
(4) The manufacturer shall draw up hygiene programmes adapted to the activities to be carried out and verify their compliance on an ongoing basis. These programmes shall in particular include procedures concerning the health, hygiene and dressing of workers.
Spaces and equipment
(1) The manufacturer shall ensure that the premises and production facilities are located, designed, constructed, adapted and maintained in such a way as to satisfy the specific requirements resulting from their use.
(2) The manufacturer shall ensure that the premises and production facilities are arranged, distributed, equipped, constructed and operated in such a way as to minimise the risk of errors and to allow effective cleaning and maintenance to prevent contamination, cross-contamination and any adverse effects on the quality of the veterinary medicinal product.
(3) The manufacturer shall ensure that premises and production facilities that are critical to the quality of veterinary medicinal products are subject to appropriate qualifications, which are repeated at regular intervals to a reasonable extent. A documented verification that the premises and facilities are suitable for the intended purpose shall be considered to be qualified. Validation means documented verification that production and control processes comply with predetermined parameters.
Documentation
(1) The manufacturer shall establish and maintain a documentation system based on specifications, manufacturing rules and instructions for processing and packaging, procedures and records affecting individual manufacturing activities. The documents must be clear, without errors and must be updated. The pre-established procedures for general production activities and the conditions, together with the documents specific to each batch, shall be maintained in such a way that they are available. This set of documents will allow monitoring of the production history of each batch. In the case of a veterinary medicinal product, the documentation relating to the production of the relevant batch shall be kept at least 1 year after the date of expiry of the lot to which it relates or at least 5 years after the issue of the certificate referred to in Article 41d (3) of the Act, whichever is the longer.
(2) Where electronic, photographic or other data-processing systems are used instead of written documents, the manufacturer shall first validate the systems by demonstrating that the data will be appropriately stored during the expected storage period. Data retained by these systems shall be easily accessible in legible form and shall be provided to the Veterinary Institute at its request. Electronic storage data shall be protected against loss or damage by methods such as copying or backup or transfer to another storage system. Any interference with the electronically stored data system shall be recorded.
Own production
(1) The manufacturer shall ensure that individual manufacturing activities are carried out according to pre-established instructions and procedures and in accordance with good manufacturing practice rules. It shall also ensure that adequate and sufficient resources are available for checks during the production process.
(2) The manufacturer shall take technical or organisational measures to prevent cross-contamination and confusion.
(3) In the case of veterinary medicinal products, the manufacturer shall validate each new manufacturing process or significant changes in the manufacturing process of the veterinary medicinal product. Critical phases of production processes are regularly and repeatedly validated.
Quality control
(1) The manufacturer shall establish and maintain a quality control unit. The quality control unit shall be managed by the person referred to in Section 41b (b). (c) the law.
(2) The quality control unit has at its disposal one or more quality control laboratories adequately occupied by staff and equipped with equipment to carry out the necessary examinations and tests of the starting materials, packaging materials and tests of intermediate products and final preparations. In the case of veterinary medicinal products, including products imported from third countries, contractual control laboratories authorised in accordance with § 41 (2) of the Act may be used, subject to the requirements laid down in § 25.
(3) During the final control of the final veterinary medicinal products before placing them on the market, the quality control unit must take into account, in addition to the analytical results, basic information such as the conditions of its own production, the results of controls during the manufacturing process and interoperational checks, the examination of the production documents and the conformity of the products with their specifications, including the final packaging.
(4) Samples of each batch of the final veterinary medicinal product shall be kept by the manufacturer for at least 12 months after the expiry date of the respective batch. Samples of the starting materials used in the manufacturing process, other than solvents, gases or water, shall be kept by the manufacturer for at least 2 years after the issue of the certificate referred to in Article 41d (3) of the Act. This period may be shortened if the period of application of the raw materials as specified in the relevant specification is shorter. All such samples shall be kept by the manufacturer so that they are made available to the veterinary institute on request. The veterinary institute may approve that, in the case of certain veterinary medicinal products which are manufactured individually or in small quantities, or the retention of which could cause specific problems, other conditions for sampling and storage of starting materials and end products are determined. Unless otherwise specified in the manufacturing authorisation, the manufacturer shall store the finished products in such a quantity as to permit double complete examination of the product in accordance with the particulars given in the registration dossier of the veterinary medicinal product.
Activities under contract
(1) A written contract between the client and the recipient of the contract must be concluded for each production or production activity carried out under the contract.
(2) The contract referred to in paragraph 1 must clearly define the obligations of each Contracting Party, in particular compliance with the rules of good manufacturing practice by the beneficiary of the contract and the manner in which the qualified person responsible for the certificate of each batch ensures that his full compliance with his responsibility.
(3) The beneficiary of the contract may not subcontract any of the activities entrusted to him by the contract without the written approval of the client.
(4) The beneficiary of the contract shall comply with the principles and guidelines of good manufacturing practice and shall be subject to checks carried out by the veterinary institute.
Complaints and downloads
The manufacturer shall establish and implement a system for recording and reviewing complaints, together with an effective system to which veterinary medicinal products from the distribution network can be immediately and at any time withdrawn. The manufacturer shall record and investigate all claims concerning quality defects. The manufacturer shall inform the veterinary institute of any quality defects likely to result in withdrawal or unusual restrictions on supply and, where possible, indicate the country of destination. If the manufacturer is not the holder of a marketing authorisation for a veterinary medicinal product at the same time, he shall take measures to ensure the rapid and effective exchange of information and coordination of measures with the marketing authorisation holder.
Internal control
The manufacturer shall carry out repeated internal checks which are part of the quality assurance system, which shall monitor the implementation and compliance with the rules of good manufacturing practice and which shall enable him to take all necessary corrective measures subsequently. The manufacturer shall keep and keep records of such internal controls and any corrective measures subsequently taken.
CONTROL LABORATORY
The rules of good manufacturing practice shall be established for the control laboratory as follows:
(a) the control laboratory shall comply mutatis mutandis with the provisions of Sections 3, 4, 6 to 9, 11 to 14, or 16 to 22 and 24 to 27 for veterinary medicinal products,
(b) the control laboratory shall issue to the manufacturer a quality check 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 MEDIATED FEED
Save as otherwise provided in this Part, the production and control of medicated feed shall be carried out under the conditions of good manufacturing practice set out in Part Three.
(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 manufacturer shall take samples from each batch of medicated feed produced, which shall be kept for at least 5 months after the expiry date of that lot.
(4) The documentation and records referred to in Article 22 shall also include the rules for medicated feed producers, the type and quantity of medicated premixtures and feed 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) The manufacturer shall ensure that 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) The manufacturer shall always refer to medicated feed as "medicated feed." In addition, the manufacturer on the packaging of medicated feed or as part of the accompanying documentation of medicated feed (§ 41k (10) of the Act) states
(a) the manufacturer of medicated feed;
(b) medicated premixtures or premixtures used for the manufacture of medicated feed;
(c) the active substance or active substances 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 and 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 label shall be indicated by the veterinary institute in its information medium.
(1) The qualified person of the manufacturer of medicated feedingstuffs (§ 41j (12) of the Act) undergoes a specialised course (§ 41j (11) of the Act) which includes teaching the following subjects:
(a) legislation of the Czech Republic and the Community on the regulation of medicinal products, including medicated feedingstuffs, and feedingstuffs;
(b) pharmacology,
(c) toxicology;
(d) the good manufacturing practice of medicated feed and feed production technology with a particular focus on homogeneity, stability and preservation of medicated feed, 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 Veterinary Institute, which shall specify in its information medium the requirements for the course. The Veterinary Institute shall carry out evaluation of the course proposals and issue opinions on the course proposals with a view to ensuring their expertise. A certificate of completion shall be issued at the end of the course.
(3) The certificate referred to in paragraph 2 or the proof of knowledge obtained in one of the Community Member States, at least to the extent specified in paragraph 1, shall be submitted by the manufacturer of medicated feedingstuffs in the context of an application for a production authorisation (§ 56) or in the context of an application for a change in the manufacturing authorisation, unless the veterinary institute 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.
(5) The manufacturer of the 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 25.
PRODUCTION OF VETERINARY AUTOGENE VACTS
Contents
ČÁST PRVNÍ
§ 1
§ 2
ČÁST DRUHÁ
§ 3
§ 4
§ 5
§ 6
§ 7
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
§ 15
ČÁST TŘETÍ
§ 16
§ 17
§ 18
§ 19
§ 20
§ 21
§ 22
§ 23
§ 24
§ 25
§ 26
§ 27
ČÁST PÁTÁ
§ 41
ČÁST ŠESTÁ
§ 42
§ 43
§ 44
ČÁST SEDMÁ
§ 45
§ 46
ČÁST OSMÁ
§ 47
ČÁST DEVÁTÁ
§ 48
§ 49
§ 50
§ 51
§ 52
§ 53
§ 54
ČÁST DESÁTÁ
§ 55
§ 56
§ 57
§ 58
§ 59
ČÁST JEDENÁCTÁ
§ 60
§ 61
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Regulation Information
| Citation | Decree No 411 / 2004 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 autogenic vaccines, amendments to the authorisations issued, as well as further conditions for the issue of authorisations for the operation of control laboratories (Ordinance on the production and distribution of medicinal products) |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 13.07.2004 |
|---|---|
| Effective from | 13.07.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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