229/2008 Sb.



DECREE



of 23 December 2003. June 2008



on the manufacture and distribution of medicinal products



The Ministry of health and Ministry of agriculture lays down pursuant to §

paragraph 114. 2 and for the implementation of § 63 para. 1 and 6, § 64 (a). (j))) and (q)) §

66 para. 4, § 69 para. 2, § 70 para. 4, § 71 para. 2 and 6, § 72 para. 1,

§ 73 para. 9 (a). (b)), section 74 para. 1 and 5, § 75 para. 2, § 76 para. 2, §

paragraph 77. 1 (b). (e)), g), (h)), and i) and § 77 para. 3 and 5 (b). a) and b)

Act No. 378/2007 Coll., on pharmaceuticals and on amendments to some related

laws (law on medicinal products):



PART THE FIRST



INTRODUCTORY PROVISIONS



§ 1



The subject of the edit



This Decree incorporates the relevant provisions of the European Communities ^ 1)

and modifies



and) the rules of good manufacturing practice and good distribution practice



(b)) the authorisation of the manufacture and distribution of medicinal products, including

medicated feedingstuffs and veterinary vaccines, as well as autogenních changes

of authorization,



(c) the issue of permits for activities) control laboratories.



§ 2



Basic concepts



For the purposes of this Ordinance, means the



and the person performing the manufacturer) activities for which it is required

authorisation pursuant to § 57 para. 1 or § 62 of the law on pharmaceuticals,



(b) quality assurance) summary of the organised arrangements made with

the aim of ensuring the quality required for their intended use of medicinal

medicinal products and investigational medicinal products; This summary includes

the rules of good manufacturing practice,



(c)) by blinding the deliberate disguising of identity of an investigational medicinal product

the product according to the instructions of the sponsor,



(d) the disclosure of the identity of a blinded unblinding) of the medicinal product,



(e) the lot reference sample sample) of the starting material, packaging,

intermediate or finished medicinal product, which is maintained under

the purpose of the analysis,



(f) the sample the sample batch) retention of the complete packing of the finished medicinal product

the product is stored for the purpose of identification; If necessary,

It can be used for analysis during the period of application of the final

of the medicinal product,



g) qualifications documented verification that the facilities and equipment are

suitable for the intended purpose, h) the validation of the documented verification that the

manufacturing and control processes meet the predetermined parameters.



PART TWO



GOOD MANUFACTURING PRACTICE FOR MEDICINAL PRODUCTS FOR



§ 3



The General principles of



(1) in the performance of the activities of the Institute in accordance with § 13 para. 2 (a). (g)), § 57 para. 3

and section 101 of the law on medicinal products shall comply with the procedures of the community

for inspection and exchange of information ^ 2) published by the European Commission (hereinafter referred to

"the Commission").



(2) the interpretation of the principles and guidelines of good manufacturing practice shall take into account

manufacturers and Institute for detailed instructions issued by the Commission ^ 3).



§ 4



For medicinal products and investigational medicinal products

imported from third countries, the importer shall ensure that such products have been

manufactured in accordance with standards which are at least equivalent to

standards of good manufacturing practice laid down by the community. The importer

In addition, medicinal products for human use shall ensure that these products

have been made with the permission of the producers of such production. An importer of investigational

medicinal products shall ensure that such products have been manufactured

the manufacturer, which has been notified to the Institute or to the competent authority in the

The community and the authority was the Institute for the purpose approved.



§ 5



Compliance with the registration of medicinal products



(1) the manufacturer shall ensure that all manufacturing operations for human

medicinal products which are subject to registration, are carried out in

accordance with the information submitted with the application for registration, as

approved by the Institute or other competent authorities in the community or in

a third country. In the case of investigational medicinal products, the manufacturer ensures

to ensure that all manufacturing operations are carried out in accordance with the data

provided by the sponsor as part of the application for authorisation or declaration

the clinical trial, as have been approved by the Institute or by other

the competent authority in the community or in a third country.



(2) if it is necessary to make the change in the registration dossier or

the change in the documentation submitted in the framework of a clinical trial application

shall notify the marketing authorisation holder, the manufacturer or the contracting entity

a clinical trial of this fact.



§ 6



The quality assurance system



The manufacturer shall establish and implement an effective quality assurance system including

the active participation of senior staff and staff of the various departments.



§ 7



Employees



(1) at each manufacturing site, the manufacturer has to work available

a sufficient number of competent and appropriately qualified employees

equipped with the necessary powers so as to achieve the objective of

quality assurance. In the fulfilment of this requirement shall take account of

above all, the nature, scale, complexity and the time course of training

production and control activities.



(2) the working tank (s) specified by the manufacturer are determined

the obligations of Directors and responsible staff, including the qualified

people who are responsible for the implementation and compliance with the rules of good

manufacturing practice. Their relations control and subordination are determined in

organizational scheme; These schemes and job description are approved

in accordance with the internal regulations of the manufacturer.



(3) the manufacturer provides its employees with initial and ongoing training and

training, whose effectiveness continuously validates; training and training include

mainly the theory and application of the principles of quality assurance and the correct

production practice and, where applicable, the specific requirements for the manufacture of investigational

medicinal products.



(4) the manufacturer shall draw up hygiene programmes adapted to the activities

to be carried out, and his staff continually validates their

compliance with. These programs include in particular those relating to the

health, hygiene practice and dress-up employees.



§ 8



Premises and equipment



The manufacturer ensures that the



and) were operating premises and manufacturing equipment sited, designed,

constructed, secured, adapted and maintained in order to meet

the specific requirements arising from the purpose of their use,



(b)) have been operating premises and manufacturing equipment laid out, designed and

operated so as to minimise the risk of error and to permit their

effective cleaning and maintenance in order to avoid contamination, cross-

contamination and any adverse effect on the quality of human

of the medicinal product,



c) premises and manufacturing facilities, which are critical for the quality of

medicinal products, subject to the corresponding qualifications and

validation.



§ 9



Documentation



(1) the manufacturer shall establish and maintain a system of documentation based on the

specifications, manufacturing formulae and processing and

packages, procedures and records for the individual carried out the production

activity. Documents shall be clear, free from errors and must be updated.

Pre-established procedures for general manufacturing operations and the conditions for

the production together with specific documents for the manufacture of each batch of maintains

the manufacturer in an accessible condition for the testing activities and their possible

the reconstruction. This file documents the manufacturer creates and maintains so that

enable the tracking of the history of the manufacture of each batch and the changes introduced during the

development of the investigational medicinal product. In the case of medicinal

of the batch documentation shall be retained for at least 1 year after the date of their

the applicability of the batches to which it relates or at least 5 years after the

issue of a certificate under section 66 paragraph 1. 3 of the law on pharmaceuticals, depending on

that time is longer. In the case of an investigational medicinal product shall

batch documentation shall be kept for at least 5 years after the completion or cessation

the last clinical trial in which the batch was used.

The adjudicating entity or the marketing authorisation holder, if this is not the same

the person responsible for ensuring that records are maintained for

subsequent registration under another law ^ 4). Part of the

system documentation is a document pursuant to § 43 para. 2 (a). (d)), which

manufacturer updates and submit to the Institute at least once every 2 years.



(2) if they are used in electronic, photographic or other systems

processing of data instead of written documents, the manufacturer shall first systems

so that is validated by the persons authorized to perform control activities could

demonstrate that the information will be during the anticipated period of storage in the light

the used data carrier appropriately stored. Data stored by these systems

must be readily available in legible form and the manufacturer shall provide to the Institute

at his request. The electronically stored data to protect against loss

or damage to methods such as copying or backing up or

transfer to another storage system. Any intervention in the system

electronically stored data it records.



§ 10



Own production



(1) the manufacturer shall ensure that the



and production activities are carried out) the individual according to previously established and

the approved instructions and procedures and in accordance with good manufacturing practice,



(b)) available human and material resources and sufficient conditions for the


carrying out inspections during the production process,



(c)) in the production process all deviations and defects of the medicinal product

documented and consistently investigated,



(d)) for the production used as starting materials only active substances,

where appropriate, the other ingredients that have been produced in accordance with the principles of

good manufacturing practice in the production of raw materials.



(2) the manufacturer accepts such technical and/or organisational measures in order to

avoid cross contamination and mix-ups. In the case of investigational medicinal products

the products of the manufacturer is paying increased attention to the treatment of these

products during each blinding and after its completion.



(3) in the case of medicinal products, the manufacturer shall be validated in every new

the manufacturing process or a substantial change to the manufacturing process of the medicinal

of the product. Critical phases of manufacturing processes are regularly and repeatedly

validated.



(4) in the case of investigational medicinal products, the manufacturer shall be validated in production

process as a whole, if appropriate, taking into account the stage of the

the development of the product. Validated, at least the critical process steps,

for example, the sterilization. All acts and parts of the design and development of the

the process is fully documented.



§ 11



Quality control of the



(1) the manufacturer will establish and maintain a quality control system. Control system

the quality of the sampling and testing, check compliance

of the medicinal product with the specifications and the Organization and documentation procedures

batch finished medicinal products.



(2) in the case of medicinal products, including those imported

from third countries, may be used by contracting the control laboratories

permitted pursuant to § 62 para. 2 of the law on medicinal products subject to the requirements

set out in section 12. In the case of investigational medicinal products shall ensure that

the contracting authority, the contracting laboratory fit the content of the application

According to § 55 para. 2 of the law on pharmaceuticals, as it has been approved by the Institute.

If the investigational medicinal products imported from third countries, analytical

control is not needed.



(3) during the final control of the batch of finished medicinal

product before its release in the distribution, sale, or for use in the

clinical evaluation of the quality control system shall take into account, in addition to

analytical results, essential information, such as conditions of its own

production and transportation, the results of checks during the manufacturing process,

review of documents on the production, including any derogations from the

procedure, and the conformity of the medicinal product with its specifications,

including the final finished pack. Final batch of medicinal

the product is part of a batch of a medicinal product

by a qualified person.



(4) the reference and retention samples of each batch of finished for

the medicinal product, the manufacturer shall, for the entire period of application and further

at least 12 months after the expiry date; the ultimate human

the product is a product, which have completed all manufacturing and

the control operations. The reference sample should be large enough to

in order to perform a complete analytical checks batch in accordance with the

registration dossiers. In the case of an investigational medicinal product

the manufacturer as instructed by the contracting authority, sufficient samples of each batch of

bulk formulated product and of key packaging components used for each batch

the finished product of at least 2 years after the completion or cessation

the last clinical trial in which the batch was used, according to

whichever is longer. Samples of starting materials used in the

the production process, in addition to the solvents, gases or water, shall be kept

at least 2 years after the release of the product. This period may be shortened,

If the shelf life of raw materials, as referred to in the relevant

specification, is shorter. For their follow-up with all

These samples shall be kept available to the competent control authorities. In

the case of medicinal products manufactured individually or in small

quantities, or medicinal products requiring special conditions

retention, the manufacturer shall follow, as regards the conditions of sampling and

retention of starting materials and of the medicinal products in accordance with the instructions

The Commission and the Agency pursuant to section 11 (b). m) of the law on medicinal products. The Institute can

specify a different sampling conditions and storage of the starting materials and

the manufacturer of the medicinal products manufactured individually or in small

quantities or whose retention requires special conditions.



(5) the qualified person, the manufacturer or importer for human use

products released batch of investigational medicinal product, if



and) in the case of investigational medicinal products manufactured in the United

Republic has been manufactured and checked in accordance with the requirements of the correct

manufacturing practice under section 64 (c). k) and (l)) of the law on pharmaceuticals, with the data in the

the specifications of the product and the documentation submitted within

applications for clinical trial



(b)) in the case of investigational medicinal products imported from a third country

has been manufactured and checked in accordance with the requirements of good manufacturing

practice at least equivalent to those laid down by Community rules,

with the information in the specifications of the product and the documentation submitted in

an application for a clinical trial,



c) in the case of an investigational medicinal product which is a comparator

product imported from a third country and which is registered in the United

Republic, has been subject to all required analyses, tests and

checks necessary to confirm its quality in accordance with the documentation

submitted in the context of a clinical trial application if you cannot apply the

the procedure under section 66 paragraph 1. 2 of the law on pharmaceuticals,



d) in the case of an investigational medicinal product which is a comparator

with imported from countries with which was enclosed the appropriate

international agreement ^ 5), and that is not registered in the Czech Republic, it was

before you enable, where appropriate, the reporting of a clinical trial examined

also, whether the



1. Comparative Medicine has been modified by a person who is the holder of the authorisation

for the manufacture of the investigational medicinal product,



2. was the proof that the product has a valid registration in the

a third country.



(6) if the entry referred to in paragraph 5 in the Member State

The community may not be investigational medicinal products are subject to other

checks, if they are imported into the United States from a Member State

Community and, where available, a certificate of release signed by

by a qualified person. This provision shall also apply in the case of human

medicinal products, unregistered under the law on pharmaceuticals,

imported for use by the doctor according to § 8 para. 3 of the law on pharmaceuticals from

Member State of the community or, in the case of medicinal products

imported for specific treatment programs under section 49 of the law on pharmaceuticals

from a Member State of the community.



(7) in the case of unregistered medicinal products in accordance with the law on

pharmaceuticals and imported for specific treatment programs under section 49 of the Act

on pharmaceuticals from a third country, the importer, the qualified person in accordance with § 64 (a).

and the law on medicinal products) have released a batch of the imported medicinal product,

If all available resources to ensure that it was made and

checked in accordance with the requirements of good manufacturing practice at least

equivalent to those laid down by Community legislation; in these

cases, the analytical review is not required.



§ 12



Activities carried out on the basis of the Treaty



(1) for each manufacturing operation or operation linked with the production closed

specifying (hereinafter referred to as "the customer") and the person who does the activity to carry out

(hereinafter referred to as "the contractor"), the written contract. The production activities of

in the repackaging of already released medicinal products may, however, the contractor

exercise only in the case of investigational medicinal products or

parallel imported.



(2) the contract referred to in paragraph 1 shall specify the responsibilities of each clear

Parties, in particular the observance of good manufacturing practice by the contractor and the

the manner in which the qualified person shall fulfil their obligations.



(3) the contractor shall not subcontract any of the work which have been

entrusted to it under the contract without the written approval of the customer.



(4) the contractor shall comply with the principles and guidelines of good manufacturing

practice and submit to the checks carried out by the Institute.



section 13 of the



Complaints, download and unblinding of medicinal product in

urgent cases



(1) the manufacturer when the introduction of the system in accordance with section 64 (c). f) and (g)) of the Act

AMG oversees, to be logged and investigated every complaint and

complaints regarding the quality of the medicinal product,

manufactures, including investigational medicinal products.



(2) the sponsor shall implement a procedure for the rapid unblinding of blinded

investigational medicinal products, if this is necessary for the immediate

withdrawal under paragraph 1. The contracting authority shall ensure that the procedure discloses the

the identity of blinded investigational medicinal product only if a

necessary.



§ 14



Internal control



The manufacturer shall conduct repeated self-inspections as part of


quality assurance, which monitors compliance with the rules of good

production practice and to allow, if necessary, subsequently, adopt

all the necessary corrective measures. About internal controls and the

all subsequently taken remedial action taken by the manufacturer takes and

keep records.



§ 15



Labelling



In the case of an investigational medicinal product labelling must be

such as to ensure protection of the subject and the return

traceability, allow the identification of the investigational medicinal product and

evaluation and facilitate the proper use of the investigational medicinal product.



PART THREE



GOOD MANUFACTURING PRACTICE FOR VETERINARY MEDICINAL PRODUCTS



The General principles of



section 16 of the



(1) the animal health department in the exercise of activities in accordance with § 16 para. 2 (a).

a) points 2 and 3, § 16 para. 2 (a). (e)) and § 101 of the law on medicinal products governed by

Community procedures on inspections and exchange of information ^ 2) published

By the Commission.



(2) the interpretation of the principles and guidelines of good manufacturing practice shall take into account

manufacturers and Veterinary Institute detailed instructions issued by the Commission ^ 3).



§ 17



In the case of veterinary medicinal products imported from third countries

ensures that these products are produced with the permission of the manufacturer

for the production of those products, that meet the standards of good manufacturing

the practice, which are at least equivalent to the good manufacturing

the practice laid down by the community.



section 18



(1) the manufacturer shall ensure that all manufacturing operations, which are listed

in the data and documentation accompanying applications for marketing

veterinary medicinal products, are carried out as they are

registered with the Veterinary Institute or other competent authority in the

The community or in a third country.



(2) if the required change in the information or documentation, on the basis of

which the veterinary medicinal product is authorised, the manufacturer shall submit to the

at the same time, if the marketing authorisation holder, Veterinary

the Institute or other competent authority in the community or in a third

the country, which the veterinary medicinal product registers, change request

registration in accordance with the rules applicable to the submission of such

of the applications. If the manufacturer is not at the same time by the mAh

for the relevant veterinary medicinal product, it shall inform the holder of the

the marketing authorisation for the veterinary medicinal product on any

circumstances that can lead to having to change registration.



§ 19



The quality assurance system



The manufacturer shall establish and implement an effective quality assurance system including

the active participation of senior staff and staff of the various departments.



section 20



Employees



(1) at each manufacturing site, the manufacturer has to work available

a sufficient number of competent and appropriately qualified employees

equipped with the necessary powers so as to achieve the objective of

quality assurance. In the fulfilment of this requirement shall take account of

above all, the nature, scale, complexity and the time course of training

production and control activities.



(2) for managers and staff, including the qualified person

or qualified persons, who are responsible for the implementation and

compliance with the rules of good manufacturing practice, shall determine the manufacturer, taking account of

to all activities carried out by relevant staff, in working

laying of workers provided by a detailed account of the scope of activities and

the definition of their responsibilities. Their control and subordination relationships

are set out in the organizational scheme; These schemes and job description

shall be approved in accordance with the internal regulations of the manufacturer.



(3) the manufacturer provides its employees with initial and ongoing training and

training, whose effectiveness continuously validates; training and training include

mainly the theory and application of the principles of quality assurance and the correct

manufacturing practice.



(4) the manufacturer shall draw up hygiene programmes adapted to the activities

to be carried out, and continuously validates compliance with them. These

programs include procedures relating to health, hygiene and

dress code for employees.



section 21



Premises and manufacturing equipment



The manufacturer ensures that:



and) were operating premises and manufacturing equipment sited, designed,

constructed, secured, adapted and maintained in order to meet

the specific requirements arising from the purpose of their use,



(b)) have been operating premises and manufacturing equipment arranged, laid out,

furnished, designed and operated so as to minimise the risk of

errors and to permit effective cleaning and maintenance in order to prevent

contamination, cross-contamination and any adverse effect on the

the quality of the veterinary medicinal product,



c) premises and manufacturing facilities, which are critical for the quality of

veterinary medicinal products, subject to appropriate qualifications, which

It is in regular intervals, repeated on an adequate scale.



section 22



Documentation



(1) the manufacturer shall establish and maintain a system of documentation based on the

specifications, manufacturing formulae and processing and

packages, procedures and records affecting the individual carried out

production activities. Documents shall be clear, free from errors and must be

updated. Pre-established procedures for general manufacturing operations and

the terms, together with the documents specific to the manufacture of each batch,

keep so that they are available. This file documents the manufacturer creates a

and maintained so as to allow tracking the history of the manufacture of each batch. In

the case of a veterinary medicinal product, the documentation concerning the

production of the batch concerned must keep at least 1 year after the date of their

the applicability of the lot to which it relates or at least 5 years after the release of

certificate referred to in section 66 paragraph 1. 3 of the law on pharmaceuticals, depending on which

time is longer.



(2) if they are used instead of written documents, electronic,

photographic or other data processing systems, the manufacturer of the first

systems shall be validated so that the data will be during the expected

with regard to the retention period the appropriately stored. Details

These systems must be kept readily available in legible form and

the manufacturer shall provide the Veterinary Institute at his request. Electronically

retained data to protect against loss or damage by methods

such as copy or backup or transfer to another system

the retention. Any intervention into the system electronically stored data

It records.



Article 23 of the



Own production



(1) the manufacturer ensures that individual production activities are carried out

by pre-established instructions and procedures and in accordance with the rules

good manufacturing practice. It also ensures that they are adequate and

adequate resources for inspection during the production process.



(2) the manufacturer accepts such technical and/or organisational measures in order to

avoid cross contamination and mix-ups.



(3) in the case of veterinary medicinal products, the manufacturer shall be validated in each

the new production process or significant changes to the manufacturing process of the health

of the medicinal product. Critical phases of manufacturing processes are regularly and

repeatedly validated.



section 24



Quality control of the



(1) a quality control Department that always the manufacturer shall establish and maintain, it is

controlled by a person referred to in paragraph 64 (a). (e)) of the law on medicinal products.



(2) the quality control Department has a laboratory or a laboratory for

quality control of reasonably occupied by employees and equipped with devices

for carrying out the necessary reviews and testing of starting materials,

packaging materials and intermediate and finished products testing. In

the case of veterinary medicinal products, including those imported

from third countries, may be used by contracting the control laboratories

authorized in accordance with § 62 para. 2 of the law on medicinal products in compliance with the

the requirements set out in § 25.



(3) during the final control of the batch of finished veterinary medicinal

product before its release into the circulation of the quality control system shall

take into account, in addition to analytical results, essential information, such as

own production and transport conditions, results of in-process

the production process, review of the documents on the production, including any

deviations from the manufacturing process, and the compliance of the veterinary medicinal product

with its specifications, including the final finished pack. Final inspection of the lot

the veterinary medicinal product is part of a system redundancy

of the medicinal product by the qualified person.



(4) the reference and retention samples of each batch of finished veterinary

the manufacturer of the medicinal product during the entire period of application and further

at least 12 months after the date of application of the batch concerned.

Samples of starting materials used in the manufacturing process, in addition to

solvents, gases or water, the manufacturer of at least 2 years after the

issue of a certificate under section 66 paragraph 1. 3 of the law on medicinal products. This period may

be shortened if the shelf life of raw materials, as referred to in

the relevant specification, is shorter. All these samples, the manufacturer


to make them available on request to the Veterinary Institute. Veterinary

the Department may approve, in the case of certain veterinary medicinal products

products that are manufactured individually or in small quantities,

or whose retention requires special conditions, were intended for other

conditions for sampling and storing the starting materials and the final

preparations. If it is not in the manufacturing authorisation provides otherwise, stores

the manufacturer of the finished product in such quantity that will allow a double full

the examination of the product in accordance with the information given in a registration

documentation of the veterinary medicinal product.



(5) the manufacturer of the finished product, that is not at the same time the holder

the marketing authorisation for the veterinary medicinal product, provides the

request samples of the veterinary medicinal product by the marketing

registration in order to meet the obligations according to § 33 para. 3 (b). (d))

the law.



§ 25



Activities carried out on the basis of the Treaty



(1) for each manufacturing operation or operation linked with the production must be

concluded a written contract between the client and the beneficiary of the contract.



(2) the contract referred to in paragraph 1 shall specify clearly the responsibilities of each

the Contracting Parties, in particular compliance with the rules of good manufacturing practice

the beneficiary of the contract and the way in which the qualified person responsible for the

certifying each batch shall ensure the full performance of their responsibilities.



(3) the beneficiary of the contract shall not subcontract any of the activities that

entrusted to him under the contract without written approval of the customer.



(4) the recipient contract must comply with the principles and guidelines for good

manufacturing practice and must submit to the checks carried out by the Veterinary Institute.



section 26



Complaints and product downloads



By the manufacturer within established systems for recording and

examination of claims and prompt the download of veterinary

medicinal products in the distribution network shall be recorded and shall investigate all

claims for quality defects. The manufacturer shall inform the animal health

the Institute of any defects in quality which could result in

a recall or abnormal restriction on supply and, if possible, the further

the country of destination. If a manufacturer is not at the same time by the mAh

the veterinary medicinal product, takes on such measures, which

ensure the rapid and efficient exchange of information and coordination of actions with the

the marketing authorisation holder.



section 27 of the



Internal control



The manufacturer shall conduct repeated self-inspections, that are part of the system

quality assurance, which monitors the implementation and compliance with the rules

good manufacturing practice and to subsequently take all

the necessary corrective measures. Of such self-inspections and any

Subsequently, the corrective measures taken and holds the leading manufacturer

records.



PART FOUR



THE RULES OF GOOD MANUFACTURING PRACTICE FOR CONTROL LABORATORY



section 28



The rules of good manufacturing practice for the control laboratory shall lay down

as follows:



and the activity control laboratories) shall apply mutatis mutandis the provisions of article 3,

4, 6 to 9, 11 to 14, in the case of medicinal products or medicinal

substances and excipients for the manufacture of medicinal products or

the provisions of § 16 to 22 and 24 to 27, in the case of veterinary medicinal products

or active substance and excipients for the manufacture of veterinary medicinal products

products,



(b) verifies the quality control laboratory) active substances or excipients

supplied to a person authorized to prepare medicinal products in accordance with the

the requirements of the European Pharmacopoeia under section 11 (b). (c)) of the law on pharmaceuticals;

If the substance is not included in the European Pharmacopoeia, in accordance with the

the requirements of the Czech pharmacopoeia under section 11 (b). (d) the law on medicinal products), or

the pharmacopoeia of a Member State and in cases where it is not even listed in the

one of these-school Pharmacopoeia, according to the requirements of a third country pharmacopoeia



(c)) expose the control laboratory for checking the quality of the manufacturer of the active substance

or excipients supplied to a person authorized to prepare medicinal

preparations of a document that contains at least the following information:



1. the name of the substance,



2. the reference to the test standard or regulation,



3. the number of the batch,



4. the expiry date,



5. an indication of the representativeness of the sample used for testing,



6. the scope of testing, including the test limits,



7. the results of the individual tests,



8. conclusion of testing,



9. the date of issue of the document



10. the identification document number on the verification of the quality, including an accounting

number control laboratories.



PART FIVE



THE MANUFACTURE OF MEDICATED FEEDINGSTUFFS



section 29



If the provisions of this part provide otherwise, and shall be used in the manufacture of

control of medicated feedingstuffs provisions of the conditions of good manufacturing

practice referred to in part 3.



section 30



(1) the manufacturer of medicated feedingstuffs removes Medicated pre-mixes for the production

the medicated feedingstuffs only from manufacturers or from medicated pre-mixes

distributors.



(2) the part of the quality control carried out by the manufacturer of medicated feedingstuffs

in particular, regular checks on homogeneity, stability,

keeping the medicated feedingstuffs manufactured and cross-contamination,

including laboratory validation.



(3) the manufacturer is taken from each batch produced of medicated feed

samples that keeps for at least 5 months after the end of the period

the applicability of a given lot.



(4) part of the documentation and records referred to in section 22 are for manufacturers

medicated feedingstuffs on regulations for medicated feedingstuffs, a records

and quantity of medicated pre-mixes and feedingstuffs used in production

Medicated feed, livestock producers address specified in the code for the

Medicated feed, identifying the Distributor, if the distribution of

medicated feedingstuffs does not own himself and identification

the veterinarian has prescribed a medicated feed production.



(5) the manufacturer shall ensure that the Medicated pre-mixes, intermediate

Medicated feed and medicated feed stored in suitable

separate and secure areas or hermetically sealed

the containers, which are intended for the storage of these products.



(6) the manufacturer shall clearly indicate the words "medicated feedingstuffs always Medicated

the feed ". In addition, the manufacturer on the packaging of medicated feedingstuffs or as

part of the documentation accompanying the medicated feed pursuant to section 74 para. 5

the law on pharmaceuticals lists



and manufacturers of medicated feed),



(b)) medikovaný premix or medicated pre-mixes used for the production of

medicated feedingstuffs,



(c)) the active substance or substances contained in the medikovaném feed with

giving the common name and concentration,



(d)) the lot number of medicated feed,



(e) the species and categories of animals), for which the medicated feed intended



(f)) special instruction for farmers, in particular the quantity of medicated

feedingstuffs in the daily ration, frequency of administration, duration of treatment and

withdrawal period,



g) expiry date of medicated feed,



h) storage conditions,



I) the treatment of unused medicated feed,



j) the indication "for animal treatment only",



to) address of the breeder, for whom the medicated feed is specified.



(7) the model designation on the package of medicated feedingstuffs shall be the Veterinary Institute

in the journal of the Institute for State control of veterinary Biologicals and

pharmaceuticals and then allowing remote access.



(8) the qualified person was not medicated feed into circulation, if the

Medicated feed has not been made, checked and marked in accordance with the

the requirements laid down by the law on pharmaceuticals, its implementing provisions,

the conditions laid down in the authorisation for manufacture or if it was not made in

accordance with a prescription for medicated feed, issued by the competent

the treating veterinarian.



(9) the medicated feed Manufacturer is entitled to arrange for part of the production or

control of medicated feedingstuffs for other manufacturers of medicated feedingstuffs or in

the case of control in control laboratories, under the conditions laid down in section 25.



section 31



(1) specialized course pursuant to § 73 para. 9 (a). (b)) of the Act, which

completing a qualified manufacturer of medicated feedingstuffs, includes

teaching



and the legislation of the United Kingdom) and the community in the field of regulation of

medicinal products, including feed and medicated feedingstuffs,



b) Pharmacology,



c) toxicology,



(d)) good manufacturing practice of medicated feedingstuffs and feed manufacturing technology

with a special focus on homogeneity, stability and keeping

medicated feedingstuffs and the problems of contamination and cleaning.



(2) the duration of the course is not less than 160 specialised teaching

hours. Organization of specialized course is coordinated by the animal health Institute,

which shall specify the requirements of the course in the journal of the Institute for the

State control of veterinary Biologicals and means that allow

remote access. The Veterinary Institute performs the evaluation of proposals and courses

issues on the draft opinions of the courses in order to ensure their professional

the filling. At the end of the course is issued a certificate of completion.



(3) a certificate referred to in paragraph 2 or proof of knowledge at least in

the scale referred to in paragraph 1 is acquired in one of the Member States

The Community shall submit to the manufacturer of the medicated feedingstuffs under the request

the manufacturing authorisation under section 43 or as part of the change request in the authorisation to


production, if there is a change of the qualified person.



PART SIX



AUTOGENNÍCH MANUFACTURE OF VETERINARY VACCINES



§ 32



If the provisions of this part provide otherwise, for the production and control of

Veterinary autogenních vaccines, the provisions concerning the conditions of

good manufacturing practice referred to in part 3.



§ 33



(1) the manufacturer of the used for the production of veterinary vaccines, with autogenních

the exception of pathogens or antigens obtained pursuant to section 71 of the law on pharmaceuticals,

only raw materials that meet quality requirements laid down in

The European Pharmacopoeia, the Czech Pharmacopoeia or the pharmacopoeia used officially

in the Member States of the community, or the quality requirements laid down in

in the advanced instructions Veterinary Institute.



(2) the manufacturer does not use for the production of veterinary vaccines autogenních

antigens or pathogens intended for submission to equidae.



(3) the notification referred to in § 71 para. 6 of the Act contains



and autogenous vaccines) the manufacturer of animal health,



(b) the composition of the veterinary autogenous vaccines) with an indication of the Antigen or

pathogens contained in veterinary autogenous vaccine,



(c)) name, address and registration number of the holding by the Central

records of where they were acquired antigens or pathogens used for the production of

veterinary vaccines and where will the autogenous veterinary autogenous vaccine

used,



d) species and category of animals which the veterinary oxyacetylene

the vaccine used,



(e)) the name, or name, surname and address workplace health

the doctor who prescribed the veterinary autogenous vaccine,



(f) the prescribed amount) of total animal health vaccines, oxyacetylene



g) date of expiry of Autogenous vaccines, veterinary



h) a special warning, if they are listed in the code of a veterinarian

for veterinary autogenous vaccine according to § 71 para. 2 of the law on medicinal products.



(4) on the internal and, where appropriate, on the outer packaging of veterinary

autogenních vaccines and in the package leaflet States



and autogenous vaccines) the manufacturer of animal health,



(b) the lot number of the veterinary autogenous) vaccines,



(c)) date of application of Autogenous vaccines veterinary; the date of the

usability is not more than 6 months from the date of manufacture of the veterinary oxyacetylene

the vaccine,



d) laboratory, which tanked antigen or pathogens, if different from the

the manufacturer,



(e) the composition of the veterinary autogenous vaccines),



(f) the name, if applicable) name, surname and address workplace health

the doctor who prescribed the veterinary autogenous vaccine,



g) indication,



h) type and category of animals for which a veterinary should be autogenous

the vaccine used,



I) breeding and location from which they were obtained antigens or pathogens

used for the production of veterinary vaccines, oxyacetylene



j) warning that the vaccine can be used only in the herd and on the holding,

where antigens or pathogens have been obtained, from which the veterinary

autogenous vaccine produced with the specific registration number

the economy, according to the central register,



k) warning that the vaccine may be used, only the attending veterinary

a doctor who prescribed by a veterinary vaccine, with the name and address of the

the workplace the competent veterinarian,



l) warning "Veterinary autogenous vaccine – before using, you must

to test the tolerance of the target animals ",



m) storage conditions,



n) the indication "for animal treatment only",



about) a special warning, if they are mentioned in the regulation of veterinary

doctor of veterinary vaccine autogenous pursuant to § 71 para. 2 of the law on

Pharmaceuticals,



p) warning for the treatment of unused or unusable

autogenous vaccine according to § 71 para. 2 of the law on medicinal products.



(5) documents the Manufacturer in accordance with section 22 dealing with antigens, or

pathogens are used for the production of veterinary vaccines and autogenních

evaluation of their applicability for manufacture of veterinary autogenních

vaccines. Part of the documentation and records referred to in section 22 are for manufacturers

Veterinary autogenních vaccines on requirements for veterinary

autogenous vaccines.



(6) in the context of quality control accepts manufacturer of veterinary autogenních

vaccines such measures, which ensures, in particular, control

the microbiological quality of veterinary vaccines in accordance with autogenních

requirements for the microbiological quality of veterinary immunologicals

medicinal products laid down in the European Pharmacopoeia and the exam

the tolerance on the target animals.



PART SEVEN



THE PRODUCTION OF ACTIVE SUBSTANCES AND EXCIPIENTS



§ 34



(1) If a provision of this part provide otherwise, shall be used in the manufacture of

active substances and excipients for the production of human and veterinary

medicinal products and their control provisions of the conditions of the correct

manufacturing practice referred to in part two, or part of a third.



(2) the manufacturer of the active substance, which produces gases used in

the provision of health care, provides each shipment of gas to

medical equipment document of quality authentication.



(3) the manufacturer of the active substance and excipients supplied to persons

authorized to prepare medicines proof of verification

the quality of the active substances or excipients, that contains the information referred to in section

28 (a). (b)), or the issuance of such a document.



(4) compliance with the requirements of good manufacturing practice in the production of the raw material manufacturer

active substances of medicinal substances manufacturer certificate attests that lists

each medicinal substance. For the requirements for an application for the issue of

a certificate for the manufacturer of the active substance and for changes to the information in this application

§ 43 shall apply mutatis mutandis.



PART EIGHT



GOOD DISTRIBUTION PRACTICE



§ 35



Policy



For standard security, distribution of medicinal products distributor



and) creates and continuously in the process and systematically applied summary

the requirements referred to in § 36-39,



b) buys and ships registered or unregistered medicinal products

medicinal products for human use ^ 6) or medicinal products intended for

specific treatment programs ^ 7), unregistered medicinal products

allowed by the State Veterinary Administration, pursuant to section 46 of the law on medicinal products in the

compliance with the conditions for the placing on the market, as the State Veterinary

the Administration established, or veterinary medicinal products registered in the

another Member State, subject to conditions set out in section 48 of the Act on

pharmaceuticals and subject to any restrictions laid down the animal health

the Institute,



c) distributes human and veterinary medicinal products, in order to

^ 8) humanitarian aid, under the conditions set out in section 39,



d) creates and maintains an effective quality assurance system,



e) agree with the persons authorized to supply medicinal products pursuant to § 82

paragraph. 2 of the law on medicinal products based on their request, of the quantity and the time

the intervals of the supplies so that medicinal products, which is a Distributor,

have been secured to the extent necessary for the purposes of the provision of health

care of the patient in the Czech Republic according to § 77 para. 1 (b). h) of the

pharmaceuticals.



section 36



Employees



(1) to ensure the storage of medicinal products and to manipulate them

secures a distributor at any point of the distribution to be carried out

the activities of a sufficient number of competent and appropriately qualified

employees.



(2) the Distributor in relation to employees working in distribution

medicinal products shall meet the following requirements: (a) establishing responsibilities and)

powers related to ensuring quality assurance system,

including sufficient powers and security equipment for qualified

person pursuant to § 76 para. 1 (b). (b)) of the law on pharmaceuticals, b) shall ensure that the

employees will be trained by a range of activities.



§ 37



Premises and technical equipment



The distributor shall ensure that the premises and technical equipment designed for

distribution of medicinal products correspond to the type and extent of

of distributed medicaments. It also ensures that these

premises and technical equipment designed, maintained, and controlled by,

in order to ensure proper handling of medicinal products.



§ 38



Documentation



(1) a Distributor shall draw up and maintain written procedures for the current

activities that may affect the quality of medicinal products or

distribution activities, such as procedures for the receipt, control of supply,

storage, cleaning and maintenance of premises, including rodent control, control

conditions of storage, including the protection of medicinal products during storage and

carriage of medicinal products, download, ordering, return and delivery.



(2) the distribution-related activities, including the implementation of the internal

checks pursuant to § 39 para. 10 and 11, and the complaints and review

the distributor keeps records.



(3) records of receipt and delivery of medicinal products include:



and the name of the medicinal product)



(b)) code assigned by the Institute of medicine or veterinary Institute,



(c)) date of receipt or shipment,



(d) the name, if applicable), name, surname, place of business of a natural person,

that is a vendor or customer and its identification number,

If it was allocated for the customer or vendor that is a legal


person, its commercial name, where appropriate, the name, registered office, address for

the delivery and the identification number, if assigned, and if the

distribution of breeders in accordance with § 77 para. 1 (b). c) point 8 of the law on

Pharmaceuticals, contain records on name, address and registration number of the

the economy, according to the central register into which the veterinary

medicines distributed;



e) details of the quantity of the purchased or sold and the identification of the supplied

medicinal products, in order to track the path of the distribution of each

of the product, including details of the time of their application,



f) the batch number;



in the management of these records, the distributor shall ensure that each item

by letter a) to (f)) were not interchangeable.



(4) the records of the distribution of advertising samples of medicinal products containing:



and the name of the medicinal product)



(b)) code assigned by the Institute of medicine or veterinary Institute,



(c)) date of delivery,



(d) the name or names), surname, or place of business of the physical

a person who is a customer, and its identification number, if

assigned at the Subscriber that is a legal entity, its business

the company, where applicable, the name, address, delivery address and identification

number, if assigned,



e) data on the quantity and identification of medicinal products supplied

in order to track the path of the distribution of each advertising sample

information about the time of their application,



f) the batch number;



in the conduct of this documentation, the distributor shall ensure that each item

by letter a) to (f)) were not interchangeable. In the case of distribution

advertising sales agents at the distributor further samples shall keep a written

the credentials of the marketing authorisation holder, in the case of advertising samples

medicinal product authorised by the holder.



(5) a Distributor also stores



and distribution of unregistered) in the case of medicinal products for

a copy of the written consent of the Ministry of health with the specific

therapeutic program under section 49 of the law on pharmaceuticals or consent of the Institute with the

their importation under § 77 para. 1 (b). I) the law on pharmaceuticals,



(b) in the case of distribution) veterinary medicinal products authorised

in another Member State pursuant to § 48 of the law on medicinal products a copy of the order

pursuant to § 48 para. 2 of the law on pharmaceuticals,



c) in the case of veterinary medicinal products distribution breeders

According to § 77 para. 1 (b). (c) section 8 of the Act) on pharmaceuticals the copy of the recipe for

distribution of breeders, which from the breeder receives the delivery

veterinary medicinal products.



(6) records carried out pursuant to paragraphs 2 to 5 shall be kept for a period of

determined in accordance with § 77 para. 1 (b). e) and (f)) of the law on pharmaceuticals and

to protect against loss, damage, or misuse.



§ 39



Distribution



(1) medicinal products stored at the distributor so that the



and storage conditions have been observed) stated on their packaging,



(b)) was introduced the system of rotation of stocks and medicines, of which the

shelf life had expired, were placed separately and not

distributed,



c) medicines is associated with impaired cover, or suspected, that the

are contaminated, have been placed in isolation and have not been distributed,



(d)) of the returned medicines were placed separately,



e) avoid their contamination, damage, theft, depreciation and

confusion;



the distributor shall ensure that, in order to avoid conflicts between documentation

conducted pursuant to section 38 and the activities undertaken in the context of income,

storage and supply of medicinal products.



(2) the carriage of medicinal products shall ensure that the distributor so that the



and storage conditions have been observed) stated on their packaging,



(b)) were not exposed to adverse impacts



(c)) are not contamination, damage, theft, depreciation and

mix-ups.



(3) the treatment of advertising samples of medicinal products shall be governed by

the provisions of paragraphs 1 and 2 shall apply mutatis mutandis.



(4) any supply of a medicinal product is accompanied by documentation which

allows you to, in accordance with § 77 para. 3 of the law on pharmaceuticals validation



and the date of dispatch,)



(b) the name of the medicinal product) and its pharmaceutical form,



(c)) of the quantities delivered and the identification of the medicinal products supplied

including details of their applicability,



(d)) of the product code assigned by the Institute or the Veterinary Institute,



(e) the names, or names), surname, place of residence of a natural person who is

the supplier and the customer, and its identification number, if

allocated; for customers and vendors, which is a legal person, its

business name, if applicable, the name, registered office and identification number, if

allocated,



f) batch number,



g) name, address and registration number of the holding in accordance with the Central

the evidence to which the veterinary medicinal products are distributed,

in the case of distribution to the producer pursuant to § 77 para. 1 (b). (c) in point 8 of the law)

on pharmaceuticals;



in the case of wholesale distribution of veterinary medicinal products in accordance with § 77 para.

1 (b). (c) section 8 of the Act) on pharmaceuticals distributor sends the information referred to in

(a) to (g))) no later than simultaneously with the dispatch of the delivery

The Veterinary Institute.



(5) returned by the medicinal product may be redistributed, if



and in the original) is a packaging,



(b)) is not exposed to adverse effects on its quality,



(c) the customer agrees to the remainder) to the time of its application, and



(d)) has been assessed by a qualified person and found to be qualified distributor

for further distribution.



(6) the medicinal products in the distribution network, for which there is reasonable

suspected of being counterfeited, the distributor separately from other

products and clearly refers to them as unsaleable. On the occurrence of these

products distributor shall immediately inform the holder of the

registration of the original product and Veterinary Institute by Institute or

their competence.



(7) advertising samples, unregistered medicinal products for ^ 6)

medicinal products intended for specific treatment programs ^ 7) or

unregistered medicinal products which are not intended for use in

The Czech Republic pursuant to section 75 para. 1 (b). (b) point 1 of the law) on pharmaceuticals,

stores the distributor separately from other medicinal products.



(8) a system download of the medicinal product from circulation in accordance with § 77 para. 1 (b).

(d)) of the law on medicinal products is set out in the written procedures governing the

Download the medicinal product imposed by the competent institution, the notified

through regional offices or carried out in cooperation with the manufacturer

or the marketing authorisation holder. This system includes

in particular:



and) the definition of responsibilities for the implementation and coordination of the download,



(b) a description of the communication) with the relevant authorities, the holder of a

registration with the manufacturer and, where appropriate, with the suppliers and customers of the medicinal

in the course of downloading the product and, where applicable, after the end of the download,



(c) a description of the custom download procedure), including the procedure for immediate

identify and contact all the customers of the medicinal product,



(d)) the way the leadership and maintain records of all activities related

downloading,



(e)) the way to download and evaluation of measures carried out in cases where the

the download is not possible,



(f) ensure the separate download location) of medicinal products.



(9) the Distributor performs the internal control repeatedly, which validates the

the implementation and observance of good distribution practices, and to adopt the necessary

the corrective measures. In the framework of internal controls performed by the distributor,

which issued the Veterinary Institute of the authorization to distribute medicinal

products at least once a year a detailed audit for the purpose of comparison

the State of the incoming and outgoing veterinary medicinal products with a

current inventory status of veterinary medicinal products. All

irregularities noted during this comparison must be recorded.

The distributor shall establish an effective system for recording and reviewing

complaints.



section 40



Distribution of active substances and excipients



(1) for the distribution of the active substances and Excipients, persons authorized to

medicinal products prepared according to § 77 para. 4 and 5 of the law on pharmaceuticals and

for the distribution of blood and its components, where appropriate, intermediate products produced from

blood and its components for further manufacturing, the provisions of this section

adequately. Sampling, laboratory inspections, filling, packaging, packing and

the marking shall be carried out on the basis of a permit to manufacture or certificate

the manufacturer of medicinal substances. Sampling and laboratory check is performed

also, on the basis of authorizations control laboratories.



(2) a Distributor of active substances and excipients supplied to persons

authorized to prepare medicinal products shall satisfy itself that the medicinal substance

or auxiliary substance has been issued with a document of verification of the quality of the active substance or

adjuvants, which contains the information referred to in section 28 (f). (c)), and ensure that

the availability of this document for a customer at his request.



(3) the Distributor, active substances and excipients supplied to persons

authorized to prepare medicinal products supplied only such substances that

at least on the packaging marked with the name of the substance, the quality specifications


substances, batch number, expiry date, storage conditions, and

the document number on the verification of the quality of the substance, including the registration number

control laboratories.



(4) in the case of active or inactive ingredients intended for the purposes of preparing

medicinal products pursuant to § 79 of the law on pharmaceuticals imported from another

Member State of the community, whose quality has been verified at least

manner equivalent to requirements on the verification of the quality of medicinal products and auxiliary

substances according to § 77 para. 5 (b). a) points 1 to 3 of the law on pharmaceuticals,

the qualified person distributor of medicinal and excipients shall certify that the

healing or excipient is authenticated accordingly based on



and the quality of the document) the active substances or excipients, drawn up

control laboratory in another Member State of the community and



(b)) of the document that confirms that the quality control laboratory is working in

accordance with good manufacturing practice, or is the holder of the certificate EN

ISO/EC 17 025.



(5) in the case of active substances or excipients, intended for the preparation of

medicinal products pursuant to § 79 of the law on pharmaceuticals imported from another

Member State of the community, a quality it is not possible to verify the procedure

pursuant to paragraph 4, the qualified person of the Distributor forwards the documentation

accompanying the substance control laboratory for examination and exposure

document referred to in section 28.



§ 41



Special rules for distribution of medicated feedingstuffs



(1) for the distribution of medicated feedingstuffs, unless otherwise stipulated,

the provisions of § 35 to 39 apply mutatis mutandis.



(2) distributors, which have been extended to permit to the distribution

distribution of medicated feedingstuffs, medicated feedingstuffs shall be taken only from the

producers who have a valid permit for the manufacture of medicated feedingstuffs.



(3) the Distributor to distribute or does not take distribute medicated

feed whose quantity exceeds the quantity specified in the regulation for the

Medicated feed pursuant to section 74 para. 2 of the law on medicinal products.



(4) only Distribute medicated feed marked, in original

intact packaging; in the case of medicated feedingstuffs distributed in

models of bulk materials are secured in these transporters

accordance with the requirements referred to in section 74 para. 8 of the law on pharmaceuticals; in these

the cases consists of the information to be included on packaging, component

documentation in the distribution of medicated feedingstuffs pursuant to section 74 para. 6 of the Act

on pharmaceuticals.



(5) the Distributor to take such measures to ensure that there is no

distributed by contamination, medicated feedingstuffs, shall in particular ensure

adequate cleaning of premises and equipment, which are used to

distribution of medicated feedingstuffs.



PART NINE



MORE DETAILED CONDITIONS FOR THE AUTHORISATION OF THE MANUFACTURE AND DISTRIBUTION OF MEDICINAL PRODUCTS



§ 42



Control activities



The Institute and the Veterinary Institute under its competence shall check the fulfilment

the requirements of good manufacturing practice for medicinal products, including

Veterinary autogenních vaccines and medicated feedingstuffs, inspection

laboratories and manufacturers of active substances and Excipients, and performance

requirements of good distribution practice for medicinal products distributors



and before issuing the permit) activities,



b) If changes to the conditions under which the activity is enabled,



(c)) at regular intervals throughout the duration of validity of the residence permit

activities or for the production of active substances and Excipients,



1. manufacturers of medicinal products at least once every 2 years,



2. for the inspection of laboratories at least once every 2 years,



3. manufacturers, active substances and Excipients, at least once every 3 years,



4. wholesale distributors of medicinal products at least once every 4 years,



5. If necessary, subsequent to the removal of deficiencies identified during

the previous inspection,



6. If required, in the case of any serious initiative in the field of

quality, safety and efficacy or in case of suspicion of

violations of the provisions of the law on pharmaceuticals and other legislation

the area of pharmaceuticals.



§ 43



Requirements for an application for a permit for the manufacture of medicinal products



(1) an application for a permit for the manufacture of medicinal products pursuant to § 63 para. 1

the law on pharmaceuticals contains



and) the name or name, last name, place of business and the identification

number, if assigned, a natural person who applies for the permit;

If such authorisation is sought legal person, business name,

where appropriate, name, address, delivery address, and identification number,

If it was allocated, the



(b)) the name or names, and surname of the statutory body or its

Members, in the case of a legal person,



(c)) the kind and range of production including quality control testing,

to be carried out,



(d) the addresses of all places) the production and quality control and the list of the

the products, including their pharmaceutical forms, where applicable, the list of

products intended for clinical trials, which will be used in these

places of production,



(e)) the name or names, surnames, education, and practice of professional

people, in the case that the qualified person has gained educational and practice outside of the

the territory of the Czech Republic, this fact shall be documented in accordance with other legal

regulation ^ 9),



f) the name or name, last name, place of business and the identification

number, if assigned, of the natural person on the basis of the Treaty

takes a part of the production or quality control; for legal persons business

the company, where applicable, the name, address, delivery address and identification

number, if assigned,



g) phone, fax and e-mail connections.



(2) the annexes to the application for a permit for the manufacture of medicinal products make up



and) an extract from the commercial register, in the case of a person registered in the commercial

indexed or provisioning the Charter or statute, issued by the competent

authority of the United States or of another Member State,



(b)), the proof of right to use the premises, buildings, rooms and equipment for the

manufacture of medicinal products,



(c) a document stating the details of) meet the requirements of good manufacturing practice

listed in the second, third, fifth, or sixth, in accordance with the requirements of

published in the journal of the State Institute for drug control and

manner allowing remote access,



d) proof of payment of an administrative fee for filing an application and proof of

perform an assessment of the request for compensation for expenses.



(3) a permit is subject to the changes to the information in the application for the authorisation for the production of

medicinal products, where appropriate, changes in the application for authorisation referred to in

paragraph 1 (b). and), c) to (f)) of this order.



(4) a request to allow changes to the data referred to in the request for authorisation to

the manufacture of medicinal products containing the information referred to in paragraphs 1 and 2,

with the changes, for which authorization is sought, shall be indicated.



(5) for the application for a permit for the manufacture of medicinal products, to the extent of imports

medicinal products from third zemí10) and a request for authorization of such changes

the authorisation shall apply, mutatis mutandis, paragraphs 1 and 2.



(6) in the case of imports from third countries shall mean data



and) referred to in paragraph 1 (b). f) data on the producers in the third country with which it has

the applicant for a licence to manufacture medicinal products in the scope of imports

medicinal products from third countries concluded a contract for the production of the imported

of the medicinal product,



(b) pursuant to paragraph 2 (e)). (b)) the list of imported medicinal products,

including their pharmaceutical forms,



(c) under paragraph 2 (b)). d) data covering the quality system and method

which the qualified person of the applicant for authorization of production of medicinal

products in the range of imports of medicinal products from third countries, verifies the

compliance with the conditions of good manufacturing practice for all production sites and

quality control in the production chain of the imported medicinal product.



§ 44



Requirements for an application for authorisation to the activity control laboratories



(1) an application for authorization to the activities of the laboratory according to § 69 para.

2 of the law on pharmaceuticals contains



and) the name or name, last name, place of business and the identification

number, if assigned, a natural person who applies for the permit;

If such authorisation is sought a legal entity, its business name,

where appropriate, name, address, delivery address, and identification number,

If it was allocated, the



(b)) the name or names, and surname of the statutory body or its

Members, in the case of a legal person,



(c) quality control) the tests to be carried out,



(d) the addresses of all places), quality control,



e) phone, fax and e-mail connections.



(2) the annexes to the application for permission to form the laboratory activities



and) an extract from the commercial register, in the case of a person registered in the commercial

indexed or provisioning the Charter or statute, issued by the competent

authority of the United States or of another Member State,



(b)), the proof of right to use the premises, buildings, rooms and equipment for the

quality control,



(c)) data on compliance with the requirements of good manufacturing practice referred to in section

Fifth, in accordance with the requirements published in the journal of the National Institute for

drug control and further manner allowing remote access,



d) proof of payment of an administrative fee for filing an application and proof of

perform an assessment of the request for compensation for expenses.




(3) the permit shall be subject to the changes referred to in the request for authorisation to

the activities of the laboratory and in the application for authorisation of the amendments referred to in

paragraph 1 (b). a), c) and (d)).



(4) a request to allow changes to the data referred to in the request for authorisation to

the activities of the laboratory contain the information referred to in paragraphs 1 and

2, with changes, for which authorization is sought, shall be indicated.



§ 45



Requirements for an application for a permit for the distribution of medicinal products



(1) an application for a permit to distribute medicinal products pursuant to § 76 para.

2 of the law on pharmaceuticals contains



and) the name or name, last name, place of business and the identification

number, if assigned, a natural person who applies for the permit;

If such authorisation is sought a legal entity, its business name,

where appropriate, name, address, delivery address, and identification number,

If it was allocated, the



(b)) the name or names, and surname of the statutory body or its

Members, in the case of a legal person,



(c)) the kind and range of distribution,



d) addresses of all the places in which the distribution is being carried out,



(e)) the name or names, surnames, education and practice, qualified

of the person,



(f)), phone, fax and e-mail connections.



(2) the annexes to the application for a permit to distribute medicinal products make up



and) an extract from the commercial register, in the case of a person registered in the commercial

indexed or provisioning the Charter or statute, issued by the competent

authority of the United States or of another Member State,



(b)), the proof of right to use the premises, buildings, rooms and equipment for the

distribution of medicinal products,



(c)) data on compliance with the requirements of good distribution practice referred to in

part eight in accordance with the requirements of the published in the journal of the National

Institute for drug control, and also in a way allowing remote access,



d) proof of payment of an administrative fee for filing an application and proof of

perform an assessment of the request for compensation for expenses.



(3) the permit shall be subject to the changes referred to in the request for authorisation to

distribution and changes in the application for authorisation referred to in paragraph 1 (b). and)

c) to (e)).



(4) a request to allow changes to the data referred to in the request for authorisation to

the distribution contains the information referred to in paragraphs 1 and 2, with changes, on the

which the authorisation is sought, shall be indicated.



§ 46



The details to request consent to import unregistered medicinal

a product from a third country



In the case of import medicinal product from a third country that is not

registered in any of the Member States or within the community and

shall be conducted pursuant to section 8 (2). 3 of the law on pharmaceuticals, presented

the Distributor when you request the Institute with this importation under § 77

paragraph. 1 (b). I) the law on pharmaceuticals, the following information:



and) the name or names of the applicant's full name and place of business if it is

a natural person, business name, or the name and address, in the case of

the legal entity,



(b) the name of the medicinal product) qualitative and quantitative content

the active substances in the medicinal product, its pharmaceutical form, and size

packaging,



(c) the identity of the manufacturer of the medicinal product) with the indication of the country of manufacture or

identify the person responsible for placing the medicinal product on the market in

third country with an indication of the country,



(d)) the address of the medical facility in which the medicinal product

prescribed or is to be used, and the name or names, and last names

the doctor who prescribed the medicine, or intends to use,



(e)) the number of packages of the medicinal product to be imported.



PART TEN



THE PROVISIONS OF THE FINAL



§ 47



Regulation (EEC)



Decree 411/2004 Coll. laying down good manufacturing practice,

good distribution practice and detailed the conditions enabling the production and

distribution of medicinal products, including medicated feedingstuffs and veterinary autogenních

vaccines, changes of authorization, as well as the more specific terms and conditions issuance

authorised laboratories (Decree on the manufacture and

distribution of medicines), is hereby repealed.



§ 48



The effectiveness of the



This Decree shall take effect on the first day of the calendar month

following the date of its publication.



Minister:



Mudr. Julínek, MBA in r.



Minister:



Mgr. Gandalovič in r.



1) Commission Directive 2003/94/EC of 8 June 2004. October 2003 laying down

the principles and guidelines of good manufacturing practice in respect of medicinal products

medicinal products and investigational medicinal products.



European Parliament and Council Directive 2001/83/EC of 6 May 1999. November

2001 on the Community code relating to medicinal products,

as amended by Directive 2002/98/EC, Directive 2003/63/EC, Directive 2004/24/EC,

Directive 2004/27/EC and Regulation (EC) no 1901/2006.



European Parliament and Council Directive 2001/82/EC of 6 May 1999. November

2001 on the Community code relating to veterinary medicinal products

medicinal products, as amended by Directive 2004/28/EC.



European Parliament and Council Directive 2001/20/EC of 4 April 2003. April 2001 on the

approximation of the laws, regulations and administrative provisions of the Member States relating to the

the introduction of good clinical practice in the conduct of clinical trials

medicinal products, as amended by Regulation (EC) no 1901/2006.



Commission Directive 2005/28/EC of 9 December 1999. April 2005, laying down the

principles and detailed guidelines for good clinical practice as regards

investigational medicinal products and also the requirements for authorisation

manufacturing or importation of such products.



Commission Directive 91/412/EEC of 23 November. July 1991, laying down the

the principles and guidelines of good manufacturing practice for veterinary medicinal products

preparations.



Council Directive 90/167/EEC of 26 June 1990. March 1990, laying down the

conditions for the preparation, placing on the market and use of medicated feedingstuffs in the

The community.



2) Summary of Community procedures concerning inspections and exchange of

information (Compilation of Community procedures on inspections and

Exchange of information) in the current version, published by the European Commission.



3) rules governing medicinal products in the European Community, EUDRALEX

Volume 4 – human and veterinary medicinal products: good manufacturing

practice (The rules governing medicinal products in the European

Community, EUDRALEX Volume 4 – Medicinal Products for Human and

Veterinary Use: Good Manufacturing Practice) in the current version

published by the European Commission.



4) Appendix 1 of Decree No. 228/2008 Coll., on registration of medicinal products

preparations.



5) such as agreement on mutual recognition in relation to conformity assessment,

certificates and designations between the European Community and Australia (OJ l.

p. 1. L 229, 17. 8.1998, p. 3), the agreement on mutual recognition in relation

to conformity assessment between the European Community and New Zealand (OJ l.

p. 1. L 229, 17. 8.1998, p. 62), the agreement on mutual recognition between the

The European Community and Canada (OJ. L 280, 16. 10. in 1998, with.

3), the agreement on mutual recognition between the European Community and the

Japan (OJ. L 284, 29. 10.2001, p. 3), the agreement between the European

community and the Swiss Confederation on mutual recognition in relation to the

conformity assessment (OJ. L 114, 30. 4.2002, p. 369).



6) § 8 para. 3 of Act No. 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products).



7) section 49 of Act No. 378/2007 Coll.



8) section 75 para. 2 of the Act 378/2007 Coll. No.



9) Act 95/2004 Coll., on conditions for the acquisition and recognition of professional

competence and specialized competence to perform the medical

the professions of doctor, dentist and pharmacist, as amended by Act No.

125/2005 Sb.