Decree No. 229 / 2008 Coll.
Order on the production and distribution of medicines
Valid
Order
Effective from 01.07.2008
Contents
ČÁST PRVNÍ
§ 1
§ 2
ČÁST DRUHÁ
§ 3
§ 4
§ 5
§ 6
§ 7
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
ČÁST TŘETÍ
§ 16
§ 17
§ 18
§ 19
§ 20
§ 21
§ 22
§ 23
§ 24
§ 25
§ 26
§ 27
ČÁST ČTVRTÁ
§ 28
ČÁST PÁTÁ
§ 29
§ 30
§ 31
ČÁST ŠESTÁ
§ 32
§ 33
ČÁST SEDMÁ
§ 34
ČÁST OSMÁ
§ 35
§ 35a
§ 35b
§ 35c
§ 35d
§ 35e
§ 36
§ 37
§ 38
§ 39
§ 40
§ 41
ČÁST DEVÁTÁ
§ 42
§ 43
§ 44
§ 45
§ 46
ČÁST DESÁTÁ
§ 47
§ 48
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229
DECLARATION
of 23 June 2008
on the production and distribution of medicinal products
The Ministry of Health and the Ministry of Agriculture shall determine, pursuant to § 114 (2) and in order to implement § 63 (1) and (6), § 64 (j), (k) and (q), § 66 (4), § 69 (2), § 70 (4), § 71 (2) and (6), § 73 (9) (b), § 74 (1) and (5), § 75 (2), § 76 (2), § 77 (1) (e), (g), (h) and (i) and § 77 (3) and (5) (a), and (b) of Act No 378 / 2007 Coll.
INTRODUCTORY PROVISIONS
Subject matter
This decree implements the relevant provisions of the European Union1) and provides for
(a) rules on good manufacturing practice and good distribution practice;
(b) authorising the production and distribution of medicinal products, including medicated feed and veterinary autogenic vaccines, as well as changes to the authorisations issued;
(c) the issue of authorisations for the operation of control laboratories.
Basic concepts
For the purposes of this decree:
(a) the manufacturer of the person carrying out the activities for which authorisation is required under Section 62 of the Drug Act;
(b) by ensuring quality, a summary of the organisational measures taken to ensure the quality required for the intended use of medicinal products; This summary includes rules on good manufacturing practice,
(c) a reference sample sample of the batch of the starting material, packaging, intermediate product or final medicinal product which is kept for analysis;
(d) by a retention sample, a sample of a batch of complete packaging of the finished medicinal product which is kept for identification; where necessary, it may be used for analyses during the period of application of the final medicinal product,
(e) the qualifications of documented verification that premises and equipment are suitable for the intended purpose;
(f) validation of documented verification that production and control processes comply with predetermined parameters.
CORRECT PRODUCTION PRACTICE FOR MEDICINAL PRODUCTS FOR HUMAN USE
General principles
(1) The Institute, in carrying out its activities under Articles 13 (2) (g) and 101 of the Drug Act, is also required to comply with Community procedures for the inspection and exchange of information2), published by the European Commission ("the Commission").
(2) In interpreting the principles and guidelines for good manufacturing practice, manufacturers and the Institute will take into account the detailed guidelines issued by the Commission3). In the case of advanced therapy medicinal products, account shall be taken of the specific guidelines for good manufacturing practice concerning advanced therapy products issued by the Commission15).
For medicinal products for human use imported from third countries, the importer shall ensure that such products are manufactured in accordance with standards at least equivalent to the standards of good manufacturing practice established by the European Union. Furthermore, importers of medicinal products for human use shall ensure that such products are manufactured by manufacturers authorised to manufacture them.
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 data submitted with the application for authorisation as approved by the Institute or by another competent authority in the European Union or in a third country.
(2) Where it is necessary to amend the registration dossier, the manufacturer shall notify the marketing authorisation holder of this fact.
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 point of production or import, the manufacturer shall have at his disposal a sufficient number of eligible and appropriately qualified staff with the necessary powers to perform their duties properly and to achieve the quality assurance objective. In compliance with this requirement, account shall be taken, in particular, of the type, extent, professional complexity and time course of production and control activities.
(2) The tasks set out by the manufacturer shall specify the responsibilities of the managers and responsible staff, including the qualified persons responsible for the establishment and compliance with good manufacturing practice rules. 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.
(4) The manufacturer shall draw up hygiene programmes adapted to the activities to be carried out by his staff and shall verify compliance with them on an ongoing basis. These programmes include, in particular, procedures relating to health, hygiene and employee clothing.
Spaces and equipment
The manufacturer shall ensure that:
(a) the premises and production facilities are located, designed, constructed, secured, adapted and maintained in such a way as to meet the specific requirements resulting from their use;
(b) 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;
(c) premises and production facilities which are critical to the quality of medicinal products for human use are subject to appropriate qualifications and validation.
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 documentation system shall ensure the quality and integrity of the data. The documents must be clear, without errors and must be updated regularly. The pre-established procedures for general production activities and the conditions for production together with the specific production documents for each batch shall be kept available by the manufacturer for the activities carried out and their possible reconstruction. This set of documents shall be developed and maintained by the manufacturer in such a way as to permit monitoring of the production history of each batch. 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 batches to which it relates, or at least 5 years after the issue of the certificate referred to in Section 66 (3) of the Medicines Act, whichever is the longer. The documentation system shall include the document referred to in Article 43 (2) (c), which shall be updated and submitted to the Institute at least every 2 years.
(2) Where electronic, photographic or other data-processing systems are used instead of written documents, the manufacturer shall first validate the systems in such a way that the persons authorised to carry out control activities can demonstrate that the data will be stored appropriately during the expected storage period with regard to the data carrier used. The data stored by these systems shall be easily accessible in legible form and shall be provided by the Institute at its request by the manufacturer. Electronic storage data shall be protected against loss or damage or unauthorised access 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) the individual production activities are carried out according to the instructions and procedures laid down in advance and in accordance with good manufacturing practice;
(b) available personnel and material resources and conditions sufficient to carry out checks during the production process;
(c) all deviations in the manufacturing 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.
(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.
Quality control
(1) The manufacturer shall establish and maintain a quality control system. The quality control system shall include the sampling and testing of samples, checking the conformity of the medicinal product with the specifications and organisation and documentation of the release procedures for final medicinal products.
(2) In the case of medicinal products for human use, including products imported from third countries, contractual control laboratories authorised under Section 62 (2) of the Drug Act may be used, subject to the requirements laid down in Section 12.
(3) During the final inspection of the batch of the final medicinal product for human use prior to its release for distribution or sale, the quality control system must take into account, in addition to the analytical results, basic information such as the conditions of production and transport, the results of the checks during the manufacturing process, the examination of the production documents, including any deviations from the manufacturing process, and the conformity of the medicinal product for human use with its specifications, including the final packaging. Final check of the batch of the medicinal product for human use is part of the system of release by a qualified person of the medicinal product.
(4) The reference and retention samples of each batch of the finished medicinal product for human use are kept by the manufacturer throughout the period of application and for at least 12 months after the date of expiry; the final human product is a product for which all manufacturing and control operations have been completed. The reference sample shall be large enough to allow complete analytical checks of the lot to be carried out in accordance with the registration dossier. Samples of the starting materials used in the manufacturing process, excluding 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 the case of medicinal products manufactured individually or in small quantities, or of medicinal products requiring special storage conditions, the manufacturer shall, as regards the conditions for sampling and storage of the starting materials and medicinal products, comply with the instructions of the Commission and the Agency under Section 11 (m) of the Medicines Act. The Institute may specify other conditions of sampling and storage of starting materials and medicinal products manufactured by the manufacturer individually or in small quantities or the storage of which requires special conditions.
(5) In the case of medicinal products not authorised under the Law on Medicines and imported for specific medical programmes under Section 49 of the Law on medicinal products from a third country, the qualified person of the importer pursuant to Section 64 (a) of the Law on Medicines shall release a lot of the imported medicinal product if he has satisfied himself by all means available that it has been manufactured and checked in accordance with the requirements of good manufacturing practice at least equivalent to those laid down in European Union rules; in such cases, analytical control is not required.
External business
(1) For each production, import or production activity or import activity, the procuring entity ("the client ') and the person to carry out the activity (" the contractor') shall conclude a written contract.
(2) The contract referred to in paragraph 1 shall clearly define the responsibility of each Party, in particular compliance with good manufacturing practice by the contractor and the manner in which the qualified person fulfils his or her obligations.
(3) The contractor may no longer subcontract any of the works entrusted to him by the contract without the written approval of the client.
(4) The contractor shall comply with the principles and guidelines of good manufacturing practice and shall be subject to checks carried out by the Institute.
Complaints and downloads
The manufacturer shall, when establishing the system in accordance with Section 64 (f) of the Medicines Act, ensure that any complaint and complaint relating to the quality of the medicinal product that he manufactures is recorded and investigated.
Internal control
The manufacturer shall carry out repeated internal checks as part of a quality assurance system to monitor compliance with the rules of good manufacturing practice and to enable it to take any necessary corrective and preventive action subsequently if necessary. The manufacturer shall record and keep records of such internal controls and any corrective measures subsequently taken.
ADMINISTRATIVE PRODUCTION PRACTICE FOR VETERINARY MEDICINAL PRODUCTS
General principles
(1) In carrying out the activities referred to in Articles 16 (2) (a) (2) and (3), 16 (2) (e) and 101 of the Medicines Act, the Veterinary Institute shall also follow the European Union 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 the Veterinary Institute 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 those products are manufactured by manufacturers authorised to manufacture those products which comply with good manufacturing practice standards at least equivalent to those of good manufacturing practice established by the European Union.
(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 in a manner that is registered by the Veterinary Institute or by another competent authority in the European Union or in a third country.
(2) Where a change to the particulars or documentation on the basis of which the veterinary medicinal product is authorised is necessary, the manufacturer shall submit an application for a change to the marketing authorisation in accordance with the rules applicable to the submission of such applications, in accordance with the rules applicable at the same time as the holder of the marketing authorisation, the Veterinary Institute or any other competent authority in the European Union or in the third country which registers the veterinary medicinal product. 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 are 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 time course of production and control activities.
(2) For the management and responsible staff, including the qualified person or qualified persons responsible for the establishment and compliance with the rules of good manufacturing practice, the manufacturer shall, taking into account all the activities carried out by the relevant staff, set out in detail the scope of the activity to be carried out and the definition of their responsibilities. 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, 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.
(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.
Space and production facilities
The manufacturer shall ensure that:
(a) the premises and production facilities are located, designed, constructed, secured, adapted and maintained in such a way as to meet the specific requirements resulting from their use;
(b) 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;
(c) premises and production facilities which are critical to the quality of veterinary medicinal products are subject to appropriate qualifications, which are repeated at regular intervals to a reasonable extent.
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 shall be developed and maintained by the manufacturer in such a way as to permit 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 Section 66 (3) of the Medicines 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 stored appropriately during the expected storage period with regard to the system used. The data kept by these systems shall be easily accessible in legible form and shall be provided by the manufacturer 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 each production activity is carried out according to the instructions and procedures laid down by him and in accordance with the rules of good manufacturing practice. 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 any new manufacturing process or significant changes to the manufacturing process of the veterinary medicinal product. Critical phases of production processes are regularly and repeatedly validated.
Quality control
(1) The quality control unit, which is always established and maintained by the manufacturer, is managed by the person referred to in Section 64 (e) of the Medicines Act.
(2) The quality control unit is provided with a laboratory or quality control laboratory adequately occupied by staff and equipped with equipment to carry out the necessary evaluation and testing of the starting materials, packaging materials and tests of intermediate products and finished products. In the case of veterinary medicinal products, including products imported from third countries, contractual control laboratories authorised in accordance with Section 62 (2) of the Medicines Act may be used, subject to the requirements laid down in Section 25.
(3) During the final inspection of the batch of the final veterinary medicinal product before its entry into circulation, the quality control system must take into account, in addition to the analytical results, basic information such as the conditions of production and transport, the results of the checks during the manufacturing process, the examination of the production documents, including any deviations from the manufacturing process, and the conformity of the veterinary medicinal product with its specifications, including the final packaging. The final check of the batch of the veterinary medicinal product shall be part of the system of release of the medicinal product by a qualified person.
(4) Reference and retention samples of each batch of the final veterinary medicinal product shall be kept by the manufacturer throughout the period of application and for at least 12 months after the expiry date of the respective batch. The manufacturer shall keep samples of the starting materials used in the manufacturing process, other than solvents, gases or water, at least 2 years after the issuance of the certificate referred to in Section 66 (3) of the Drug Act. This period may be shortened if the period of application of the raw materials as specified in the relevant specification is shorter. All these 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 produced individually or in small quantities, or which require special conditions, other conditions for sampling and storage of starting materials and final 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.
(5) The manufacturer of the finished product, which is not the holder of the marketing authorisation for the veterinary medicinal product, provides samples of the veterinary medicinal product to the marketing authorisation holder on request in order to fulfil the obligation under Article 33 (3) (d) of the Act.
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.
(2) The contract referred to in paragraph 1 shall 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
Within the framework of its established systems for recording and reviewing complaints and the immediate withdrawal of veterinary medicinal products from the distribution network, 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.
RULES OF CORRECT PRODUCTION PRACTICE FOR THE CONTROL LABORATORY
(1) The provisions of this Regulation shall apply mutatis mutandis to the operation of the control laboratory.
(a) Articles 3, 4, 6 to 9 and 11 to 14, if it is for medicinal products for human use or active substances and excipients for the manufacture of medicinal products for human use; or
(b) Articles 16 to 22 and 24 to 27, if it concerns veterinary medicinal products or active substances and excipients for the manufacture of veterinary medicinal products.
(2) The control laboratory shall issue evidence of the quality of the active substance or of the excipients supplied to persons authorised to prepare medicinal products.
PRODUCTION OF MEDIATED FEED
Unless otherwise provided for in this Part, the provisions on good manufacturing practice set out in Part Three shall apply in the manufacture and control of medicated feedingstuffs.
(1) The manufacturer of medicated feedingstuffs only collects medicated premixtures for the manufacture of medicated feedingstuffs from manufacturers of medicated premixtures or from 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 clearly identify medicated feed by the words "medicated feed '. In addition, the manufacturer on the packaging of medicated feed or as part of the accompanying documentation of medicated feed referred to in Section 74 (5) of the Medicines Act states
(a) the manufacturer of medicated feed;
(b) medicated premix or medicated premixes used for the manufacture of medicated feed;
(c) the active substance or active substances contained in medicated feed, indicating the normal 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 of labelling on the packaging of medicated feedingstuffs shall be indicated by the Veterinary Institute in the Bulletin of the Institute for State Control of Veterinary Bioprafts and Medicines and in a way that allows remote access.
(8) A qualified person shall not release medicated feed into circulation if the medicated feed has not been produced, controlled and labelled in accordance with the requirements laid down in the Law on Medicines, its implementing provisions, the conditions laid down in the authorisation for manufacture, or if it has not been produced in accordance with the prescription for medicated feed issued by the competent treating veterinarian.
(9) 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.
(1) The specialised course referred to in § 73 (9) (b) of the Act, which is completed by a qualified person of the manufacturer of medicated feedingstuffs, includes teaching
(a) legislation of the Czech Republic and the European Union on the regulation of medicinal products, including feedingstuffs and medicated feedingstuffs;
(b) pharmacology,
(c) toxicology;
(d) 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 the requirements for providing the course in the Bulletin of the Institute for State Control of Veterinary Bioprafts and in a way that allows remote access. 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, to the extent that it is obtained in one of the Member States of the European Union, shall be submitted by the manufacturer of medicated feed in the context of an application for a production authorisation pursuant to Paragraph 43 or in the context of an application for a change in the manufacturing authorisation, if the qualified person changes.
PRODUCTION OF VETERINARY AUTOGENE VACTS
Unless otherwise provided in this Part, the provisions on good manufacturing practice set out in Part Three shall apply in the manufacture and control of veterinary autogenic vaccines.
(1) The manufacturer uses only those raw materials which comply with the quality requirements laid down in the European Pharmacopoeia, the Czech Pharmacopoeia or the pharmacopoeia officially used in the Member States of the European Union or the quality requirements laid down in the specific instructions of the Veterinary Institute for the manufacture of veterinary autogenic vaccines, with the exception of pathogens or antigens obtained under Section 71 of the Medicines Act.
(2) The manufacturer does not use antigens or pathogens intended for administration to equidae for the manufacture of veterinary autogenic vaccines.
(3) The notification under Paragraph 71 (6) of the Act contains:
(a) the manufacturer of the veterinary autogenic vaccine;
(b) the composition of the veterinary autogenic vaccine, indicating the antigens or pathogens contained in the veterinary autogenic vaccine;
(c) the name, address and registration number of the holding according to the central register where the antigens or pathogens used for the manufacture 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, where appropriate, the name, surname and address of the place of work of the veterinarian who prescribed the veterinary autogenic vaccine;
(f) the total prescribed amount of the veterinary autogenic vaccine,
(g) the date of application of the veterinary autogenic vaccine;
(h) specific warnings if they are provided in the veterinary prescription for the veterinary autogenic vaccine provided for in Section 71 (2) of the Drug Act.
(4) The internal and, where appropriate, the external packaging of veterinary autogenic vaccines and the package leaflet should include:
(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 / or the name, surname and address of the place of work of the veterinarian who prescribed the veterinary autogenic vaccine;
Contents
ČÁST PRVNÍ
§ 1
§ 2
ČÁST DRUHÁ
§ 3
§ 4
§ 5
§ 6
§ 7
§ 8
§ 9
§ 10
§ 11
§ 12
§ 13
§ 14
ČÁST TŘETÍ
§ 16
§ 17
§ 18
§ 19
§ 20
§ 21
§ 22
§ 23
§ 24
§ 25
§ 26
§ 27
ČÁST ČTVRTÁ
§ 28
ČÁST PÁTÁ
§ 29
§ 30
§ 31
ČÁST ŠESTÁ
§ 32
§ 33
ČÁST SEDMÁ
§ 34
ČÁST OSMÁ
§ 35
§ 35a
§ 35b
§ 35c
§ 35d
§ 35e
§ 36
§ 37
§ 38
§ 39
§ 40
§ 41
ČÁST DEVÁTÁ
§ 42
§ 43
§ 44
§ 45
§ 46
ČÁST DESÁTÁ
§ 47
§ 48
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Regulation Information
| Citation | Decree No. 229 / 2008 Coll., on the production and distribution of medicines |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.06.2008 |
|---|---|
| Effective from | 01.07.2008 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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