84/2008 Sb.



DECREE



of 26 March. February 2008



on good laboratory practice, detailed the conditions of treatment with drugs in

pharmacies, medical devices and for other operators and

devices producing medicines



Change: 254/Sb.



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

paragraph 114. 2 and to implement section 2 (2). 2 (a). (c)), § 5 para. 4, § 8 para.

1, § 39 para. 3, § 77 para. 5 (b). (b)), § 79 paragraph 2. 1 (b). (c)), section 79

paragraph. 2 and 8 (b). a) and (c)), § 79 paragraph 2. 10, § 82 para. 1 and 3 (b). b), §

paragraph 82. 4, § 83 para. 1 and 3, § 83 para. 5 (b). (b)), § 84 paragraph. 3 and §

paragraph 85. 1 of law No 378/2007 Coll., on pharmaceuticals and on changes of some

related laws (law on medicinal products):



PART THE FIRST



INTRODUCTORY PROVISIONS



§ 1



According to this order are the procedures for the preparation, modification, storage,

receiving and dispensing of medicinal products in the pharmacy, at the workplace, nuclear

medicine with immunological, microbiological or workplace, in

devices to protect public health and to deal with the active

preparations in the provision of health services and health care.



§ 2



For the purposes of this Ordinance, means the



and individual preparation preparation of) a medicinal product for an individual

the patient according to the rules specified in § 79 of the law on pharmaceuticals,



(b) preparation of an intermediate mail preparation) intended to further

processing on the same healthcare providers or final

product a medicinal product without a prescription

prescribed for a particular patient or a particular animal,



(c) a radiopharmaceutical prepared radiopharmaceutical) such that

ready for a patient or group of patients to a specific

the examination,



(d)) activity of the forthcoming radiopharmaceuticals the amount of activity in medicine

of the given date and time,



e) standard operating procedure document which sets the repeating

activities,



f) pharmaceutical form of the medicinal product the technological processing of medicinal

substances and Excipients, characterised by the shape, composition and physical

structure, having regard to the physical structure of the formulations to be broken down to

formulation of solid, semi-solid and liquid, having regard to the shape is divided into

formulation of split and nonsplit; a detailed breakdown of the pharmaceutical form is the

contained in annex 1 to this notice.



PART TWO



THE RIGHT OF PHARMACEUTICAL PRACTICE AND THE MORE DETAILED CONDITIONS FOR OPERATION OF PHARMACIES



§ 3



Principles for the preparation of medicinal products



(1) for the preparation of medicinal products are used



and) of the active substance and excipients listed in the Czech Pharmacopoeia ^ 1) or in the

the list of active substances and excipients ^ 2) with proof of

quality ^ 3) (hereinafter referred to as the "certificate"),



(b) authorised medicinal products) ^ 4), which is not the way to use

listed in the approved summary of product characteristics, only if

If it is not present on the market a medicinal product that allows dosage

indicated on the recipe prescribed by a doctor



(c) enabling the accuracy of the weight in grams) active substances and excipients of

one order of magnitude higher than navažované quantity



(d)), the working items, tools, instruments, devices and packaging, made

from materials that do not affect the properties of the medicinal products.



(2) in the preparation of medicinal products



and all documents) so that it can be detected

the procedure for preparation and evaluation of quality; If the documentation is kept

electronically, the data is backed up soft



(b)), you cannot use the active substances and Excipients, after the expiry of their

application, or if there are deficiencies in them when

organoleptic inspection



(c)) shall be applied so as to exclude the possibility of confusion,



(d) a health professional) ^ 5) cannot be prepared at the same time more

various medicinal products,



e) cannot be used triturace, which means the well spread a mixture of medicinal

substances with other ingredient, usually with evinced resistance, or a solution of the drug substance with

the other ingredient, allowing for accurate weighing, the ratio of the active substance,

If it contains venena ^ 1), narcotic drugs or psychotropic substances

not operator control laboratories ^ 6) or pharmacy performed

review of identity and the content of these substances,



(f)) of the device which can affect the quality of the finished medicinal product

the product, regularly cleaned and checked.



(3) ^ 1) purified water can be stored at a temperature of not more than 25th. (C) and

use it for preparing medicinal products for a maximum period of 24 hours from the

her training; If after preparation, stored at 2-8th. (C),

You can use it for a maximum period of 72 hours. Longer can be

admit it, if it is accompanied by the stability studies. Purified water

held by in a closed system equipment for the preparation of purified water can be

used for the preparation of medicinal products at the time determined on the

the basis of the validation process.



(4) water for injections in airtight packages can be held by the

the preparation of medicinal products, the use for a maximum period of 24 hours from the time of

violation of the integrity of the packaging. However, if used as a water purified and

stored at 2-8th. (C), you can use it for a maximum period of 72

hours.



(5) the sterile medicinal products are prepared on the premises with prescribed

by the purity of the air, which should be periodically inspected; class of cleanliness

air are listed in Appendix 2 of this order.



(6) in the preparation of parenteral medicinal products group of anti-cancer agents

shall comply with requirements established for the preparation of sterile medicinal

preparations and requirements based on the specific nature of the active substances.



(7) in the preparation of radiopharmaceuticals shall comply with the requirements for working with

Open radionuklidovými the radiator under another law ^ 7).



(8) in the preparation of medicinal products, in addition to the procedures referred to in section 5 to

7 considers whether or not



and deliberation, weighing)



b) filling, packaging,



(c)) the distribution of individual packages of authorised medicinal products

for providers of health services,



d) scheme, which was disproportionately difficult or hazardous, in particular

Edit



1. radiopharmaceuticals,



2. injectable anti-cancer agents,



3. medicinal products for gene therapy,



4. medicinal products intended for parenteral nutrition.



§ 4



The editing policy of medicinal products



(1) for the adjustment of the medicinal product is considered to be the dilution of registered

medicinal products other than those referred to in § 3 (1). 8 (a). (d)), dissolving or

dilution of syrups, powder for the preparation of injectable products and adding

injectable solutions into infusion when they are performed in the containers intended for

this purpose, or in the case of sterile medicinal products using

medical devices guaranteeing the sterility.



(2) the authorised medicinal products can be edited only the procedures that

are in accordance with the summary of product characteristics ^ 8), in the case of

ance ^ 9) according to the manufacturer, under the conditions

set out the specific therapeutic program ^ 10) or, under the conditions

approved for the conduct of the trial ^ 11). In the case of the use of

medicinal product pursuant to section 8 (2). 3 (b). (b) point 1 of the law) on pharmaceuticals,

It can be edited under the conditions given by the manufacturer, as foreign

Summary of product characteristics. In the case of the use of the medicinal product in accordance with §

8 (2). 3 (b). (b) point 2 of the Act) on pharmaceuticals, it can be edited by

the manufacturer's instructions included in the documentation accompanying the medicinal product

for advanced therapy medicinal products.



(3) when using the purified water and water for injections for the adjustment of the medicinal

of the process according to § 3 (2). 3 and 4 apply mutatis mutandis.



§ 5



Preparation of sterile medicinal products



Preparation of sterile medicinal products



and sterile material of parenteral) technology, which eliminates the

biological, microbiological, chemical or physical contamination,

performed in the workspace class of purity of the air and that is located

the purity of the air in the airspace of class C,



(b)) shall be conducted in the area of parenteral class cleanliness C;

sterility requirement ensures thermal or microbial filtration in

the workspace cleanliness and class; in the same way

prepare other sterile medicinal products without additives, antimicrobial medications for regular



(c)) with the addition of antimicrobial medications for regular is topped by a microbial filtration and

rozplňováním in the workspace cleanliness and class or in

If the nature of the medicinal product makes it possible, followed by heat

sterilization,



(d)) that cannot be sterilized, takes place in the airspace of class

the purity of the air and that is located in the area of air purity class C;

for their preparation shall apply sterile active substances and Excipients,



e) containing cytotoxic compounds shall be carried out in a vacuum

Security boxes with vertical laminar flow class of purity

air and exhaust and outside space, which are located in the airspace of class

the purity of the air (C) and are reserved for this purpose,



(f)) for gene therapy is done in a vacuum of security boxes

with vertical laminar flow class with the purity of the air and and with take-off


outside the premises, which are located in the area of air purity class B and

are reserved for this purpose.



§ 6



Individual preparation



(1) if the maximum dose of active substances provided for in the Czech

Pharmacopoeia ^ 1) or therapeutic dose, maximum dose is not

fixed, and this is not a prescriber providing

health care or a veterinarian duly stamped and is not meant to

verify this information with the appropriate prescriber, pharmacist adjusts

quantity or concentration prescribed therapeutically active substance on

the usual ^ 1), change be indicated on medical prescription and confirm it with your

signature. Appropriate prescribing physician about this change, pharmacist

shall inform without delay.



(2) if the medicinal product prepared according to prescription

According to the knowledge and experience did not meet the quality requirements, the pharmacist

safety and efficacy, in particular when the prescribed medicine

contains substances incompatible or such, which are known to be

can negatively affect each other, the pharmacist will modify the medical

Act within the meaning of the qualitative or quantitative changes of the auxiliary

substances or medicinal substances. This change be indicated on medical prescription,

confirm it by his signature and the medicinal product shall prepare and, acting in accordance with the

made the change. In the case of changes to the active substances shall be made after this change

the previous agreement with the prescriber providing health care

or veterinarian.



(3) if it is possible to improve the properties of the medicinal product, using the appropriate

excipients, the pharmacist may perform a composition adjustment

of the product. The change indicated on medical prescription, shall acknowledge his signature and

medicine prepares and issues in accordance with the change.



§ 7



Mail preparation



(1) Mail preparation is carried out according to the process, which

means the progress of the preparations and prescribing documentation controls

of the product,



and) to 20 packs of the finished product a medicinal product pursuant to section 3, 5 and 6

and according to § 9 para. 1 and 2,



(b)) over 20 packs of the final product of the medicinal product, in batches according to the

§ 3, 5 and 6 in accordance with § 9 para. 3,



c) over 20 packs of the final product of the medicinal product, in batches according to the

§ 3 para. 8 (a). and (c))) and with the procedure laid down in point (a)),



d) drawn up for the intermediate.



(2) No process shall be carried out in accordance with § 2 mail preparation

(a). (b)), if it does not occur repeatedly.



§ 8



Labelling of active substances, excipients and pharmaceutical substances



(1) the packaging in which shall be kept for the active substances and Excipients,

shall be made unless it is marked directly on the cover firmly lpícím the label,



and a diagonal blue stripe) from the lower left to the upper right corner of the label

in the case of narcotic drugs and psychotropic substances ^ 12)



(b)) in white on a black label with venen,



c) red lettering on a white label on the separand,



d) black letters on a white label in cases not referred to in subparagraphs)

(c)),



(e)) in addition to the markings referred to in points (a) to (d))) a warning text

"Flammability" active substances and excipients flammable flammable and

"Corrosive" for the active substances and Excipients, corrosive corrosive.



If it is not a trade or the original packaging, is part of the

marking certificate number and lot number.



(2) Prepared medicinal products intended to supply to indicate



and white label), in the case of medicinal products intended for use by mouth,

the absorption of the mucous membranes of the oral cavity or injection,



(b)) a red label with the inscription "euthol", in the case of other

applications,



c) in the case of medicinal products intended for animals, according to subparagraph (a)), or

(b)) and a green label with the words "only for animals!"



(d) the address of the pharmacy); If the medicinal product issued another pharmacy than

the one that it has prepared, also marks the address issuing the pharmacy,



(e) the date of preparation and) if the shelf life is shorter than 48

hours, even an hour of preparation,



f) signature of the person who prepared the medicinal product, in the case of the preparation of the

According to § 6 and 7 (2). 1 (b). and § 7 (1)). 2,



(g)) of a batch of a medicinal product, in the case of preparation pursuant to § 7 para. 1 (b).

(b)), and (c)),



h) expiry date of the medicine, which means the length of time

in compliance with the prescribed method of storage of the medicinal product

retains its declared properties or properties needed for

intended use, its retention and an instruction manual, which

contains, in particular, how to use and dosage of the medicinal product, if

having regard to the nature of the medicinal product must be indicated,



I) used antimicrobial medications for regular, if ingredient when preparing added;

the eye preparations without antimicrobial medications for regular ingredients shall be marked with the symbol

"SA"



(j)), "poison", if it is on medical prescription by the doctor providing the

health care or veterinary surgeon specifically stated,



the composition, or name), in the case of medicinal products

prepared pursuant to § 7 or medicinal products intended to issue, for

providers of health services or for veterinary surgeons,



l) the total quantities of the medicinal product, it is not the individual

preparation under section 6,



m) on behalf of, or with the names, last name, identification number

the patient-the insured person; If the identification number was not assigned, date

the birth of the patient and the words "cytotoxic", in the case of medicinal

products group of anti-cancer agents,



n), on behalf of, or with the names, last name, identification number

the patient-the insured person; If the identification number was not assigned, date

the birth of the patient and the words "gene therapy", in the case of medicinal products

the gene therapy



about) on behalf of, or with the names, last name, and identification number of the

the patient-the insured person; If you have not assigned identification number, date of

the birth of the patient, in the case of parenteral pharmaceuticals prescribed

for a particular patient,



p) says "fire hazard", in the case of medicinal products flammable ^ 13), and

the inscription "Corrosive", in the case of medicinal products, corrosive ^ 13).



If used, the outer packaging shall be at least the particulars referred to in points (c)), g),

h), (j)), k), (l)), m), n), o) and (p)).



(3) the designation of intermediate products of medicinal products includes



and the name or composition),



(b)) the degree of completion, if developed,



(c)) date of preparation,



(d)) the expiry date,



e) signature that wrote.



(4) the medicinal products that are edited and are intended to supply for the

providers of health services or for veterinarians, shall be

the name or composition, the data referred to in paragraph 2 (a). a) to (f)), h), (j)) l)

and p), if these data are no longer listed on the packaging of the adjusted

of the medicinal product, where appropriate, the particulars identifying the patient according to the

a prescription.



(5) the distribution of the individual packages of registered medicines

products, these products indicate the name, strength or concentration,

lot and expiry date, if such data are no longer on the packaging

listed; at termolabilních medicinal products shall indicate whether or not the conditions

their retention.



(6) the Reagents for laboratory use, prepared in the pharmacy are referred to

yellow label with the words "Zkoumadlo" and disinfection solutions Red

label with the inscription "solution for disinfection".



(7) the investigational medicinal products within the framework of a clinical trial (hereinafter referred to as

"investigational medicinal product") must be labelled with the supplied

by the contracting authority with information pursuant to § 19 of the good clinical

practice ^ 37). In the case that the investigational medicinal products are prepared or

before dispersing, the further information referred to in paragraph 2 (a).

d) to (f)), and (h)).



§ 9



Check when receiving, preparing and editing



(1) in the case of medicinal products prepared checks the issuing person

appearance, quantity, packaging and marking.



(2) in the case of medicinal products prepared in bulk to 20 Pack final

the product of the medicinal product, the person who checks the medicine

prepared, the certificate used active substances and Excipients and

the completeness of the documentation.



(3) in the case of medicinal products prepared in bulk in quantities over 20 packs

the final product of the medicinal product is made in the input, process

and according to the pre-established inspection documentation. After the release of

medicinal products prepared in batches with a sample of each batch

stores after the expiry date.



(4) in the case of medicinal products prepared by repeatedly on the requisition of their

preparation and inspection is carried out according to the process or by

the standard operating procedure for these cases by

under section 22.



(5) in the prepared pure water check is made



and) chemical and physico-chemical,



1. at least once every 2 months and



2. after each intervention into its preparation,



b) microbiological, and at least twice a year.



When you check the pure water the process according to the Czech Pharmacopoeia ^ 1).




(6) prior to the use of active substances and excipients shall be carried out for each

Pack the organoleptic test.



(7) after adjustment for medicinal products, a check is made in accordance with paragraph 1.



Of medicinal products



§ 10



(1) registered medicinal products shall be issued in accordance with the decision of the

registration ^ 2), and in particular with the summary of product characteristics. Part of the

the issue is to provide the information necessary for the proper and safe

the use of medicinal products issued and for their retention.



(2) in the pharmacy to collect and process information about suspected

serious or unexpected adverse reaction, and other facts of serious

for the health of the people related to the use of the medicinal product and

defects in the quality of medicinal products which are brought in connection with the

issue and this information shall be notified to the National Institute for

drug control.



(3) in the case of medicinal products issued by the patient on a prescription the pharmacist verifies the

before dispersing, indicated dosage and stamped application; When

issue



and) may suspend the release of medicinal products, if, in his

knowledge and experience in their application could be

the mutual influence of undue or damage to the health of the patient; This

the fact shall consult with the prescriber or health

the doctor and in the case of the medicinal products, unreachable

There is a risk of default ^ 15); any changes to the reason for refusing the

Notes on a recipe,



(b) the number of packages) issues of the medicinal product, expressed in words, if the

recipe number of packaging, given the conflict between the numeral and the verbal indication,



(c)) shall consult with the prescriber,



1. If, in the case of the prescription of a medicinal product shall pay, from the public

health insurance according to the law on public health insurance,

the conflict between the main diagnosis cited in the case required an increased

payment of the prescribed medicinal product and information about indications, this

a medicinal product referred to in the summary of product characteristics and the

the fact is not on the recipe indicated by the symbol "(!)"



2. If the word "(!)" in the case that the dosage is exceeded

the corresponding SPC or referred to in the Czech Republic

Pharmacopoeia,



(d)) is not provided the symbol "(!)" and the prescriber is unreachable,



1. in the case referred to in point (c)) point 1 of the prescribed medicinal

medicine,



2. shall be adjusted in the case referred to in point (c)), point 2 of the dosage

the corresponding SPC or referred to in the Czech Pharmacopoeia

and inform about the prescribing physician as soon as possible,



e) more than one package of one kind of the prescribed medicinal

of the product paid by the public health insurance under the law on

public health insurance shall issue such number of packages which corresponds to the

ensure the treatment of a patient for a period of three months, if the prescribed number of

packaging exceeds this limit.



(4) if the medicine prescribed by the international non-proprietary name

the recommended World Health Organization with an indication of the desired

pharmaceutical forms, strengths and quantities, the pharmacist shall issue the corresponding medicinal product

the product with the lowest payment for the patient. With the consent of the patient

the pharmacist can give a medicine which supplement is not the lowest.



(5) a pharmacist prescribed the medicinal product, in the absence of the recipe



and the signature of the prescribing physician),



(b)) identification of providers of health services, which was a recipe

exposed, cannot be completed and there is no danger of default,



(c)) the signature of the approved veterinarian and the identification of the person entitled

provide veterinary care, if the medicinal product specified

for the animal,



(d)) the name, or first and last name of the patient and cannot be supplemented, if

It's not about the prescription of a medicinal product in the case of risk of default

in the provision of health care to a patient who is in danger of death

or appears to be a serious health disorders,



(e) the patient's identification number)-the insured person and his health code

the insurance undertaking; If the identification number was not assigned, date of birth

the patient, and cannot be added to it, or



(f)) first and last name of the keeper, in the case of medicinal product

destined for a beast and cannot be added.



§ 11



(1) if it is not available at the pharmacy the prescribed medicine and its

the immediate issue is with regard to the health of the patient is necessary, it may

the pharmacist to issue other than the prescribed medicine in the case that



and with such a procedure) the patient agrees, and the medicine is the same as from

the efficiency and the safety and



(b)) the medicinal product contains the same active substance with the same path

Administration and in the same dosage form; This does not apply for investigational medicinal products

preparations; If the medicinal product contains different quantity of the active

substances per unit of weight, volume or dosage forms, the pharmacist will adjust

his dosage to match the dosage prescribed by your doctor.



(2) Nevyznačí to the prescriber that insists on the release of the prescribed

of the medicinal product, the pharmacist can make when the conditions referred to in paragraph 1

(a). a) and b) issue other than the prescribed medicine.



(3) if the pharmacist in accordance with paragraph 1 or 2, shall mark the recipe

issued by a medicinal product, including any changes in payment and dosage.



(4) Replace prescribed medicine for another medicinal product with the

another active substance with similar therapeutic effects or any other drug

the pharmacist can form only, provided that the patient agrees,

swap is approved prescriber and carried out substitution

be indicated on the recipe, including the dosage.



(5) when the supply of the medicinal product prescribed by the veterinarian,

proceed according to the provisions of paragraphs 2 to 4 apply mutatis mutandis.



§ 12



(1) a recipe, and the recipe from the recipe listing, on which to repeat the issue

prescribed medicinal product when dispensing must affix the



and pharmacy)



(b) the date of issue) prescribed the medicinal product,



(c) the signature of the issuing pharmacist); in the case of an electronic recipe

the signature of the issuing pharmacist is replaced by its advanced electronic

signature based on a qualified certificate in accordance with the law on

electronic signature ("electronic signature")



(d)) or "fee no selected" ^ 16).



(2) for the supply of medicinal products without a prescription with

by limiting ^ 17) a pharmacist shall verify whether the conditions are met, the restrictions

laid down in the decision on registration, identity of the person requesting checks

medicinal product and such a person shall provide the information necessary for the

safe use of the medicinal product.



(3) issue on electronic recipe issues a pharmacist dispense

the product solely on the basis of the identification of the character communicated to the patient

prescriber.



(4) after the supply of the medicinal product to an electronic recipe

the pharmacist shall be sent by the issuing central store of electronic

recipes ^ 18) electronically information about picking.



(5) in the case of the acquisition of the electronic statement of the recipe is followed

under another law ^ 19).



(6) the dispensing of medicinal products is not restricted by § 39 para. 5

the law on pharmaceuticals or is not subject to medical prescription, can be issued and

self-service way in the areas of Pharmacy laid down for that purpose,

as well as the shipping method.



section 13 of the



Records of dispensing



(1) with regard to the issue on the basis of an electronic recipe, issuing

the pharmacist shall make a record of keeping supply that contains



and putting the patient's identification number)-the insured person; If

been allocated identification number, date of birth of the patient,



(b)) code of the medicinal product given to the State Institute for drug control,



(c)) the amount of the medicinal product,



(d)), issue date,



(e) the identification of the issuing pharmacist) and the identity of the pharmacy, where he was

picking takes place.



(2) a record of the issue are created through the information system

the issuing pharmacist, is complemented by electronic identification signs

prescription and medicinal products issued on its basis so as to

possible in the central store of electronic recipes pair

electronic recipe to a record about the issue, and prescribed medicines

actually issued.



(3) a record of the issue is through the information system

the issuing pharmacist sent in the format of a standard Extensible

Markup Language-XML (hereinafter referred to as "markup language") to a central

electronic storage of recipes.



(4) the central repository shall send by return e-recipes

the information system of the issuing pharmacist acknowledgement of receipt,

processing and saving the record on the issue. Part of this confirmation is

the pairing with electronic recipe to a record about the issue, and

prescribed medicinal products is actually issued.



§ 14



To change the data in the record on the issue, sent to a central repository

electronic prescriptions




Changes to the information in the record about the issue, which has been confirmed by the adoption,

sent through the information system of the issuing pharmacist

a central repository of electronic recipes in markup format

of the language. To send changes to the data in the record about the issue, and how central

store electronic prescriptions § 13 para. 2 to 4 apply mutatis mutandis.



§ 15



The cancellation of the recording of the issue presented to the central store

electronic prescriptions



(1) record on the issue, sent to a central repository of electronic

recipes, the issuing pharmacist cancel



and in the event of new) facts unknown at the time of despatch,



(b) in the case of a bad copy of) a record of the issue presented to

a central repository of electronic prescriptions,



(c)) in another when necessary;



and at the same time ensure the download of a medicinal product from the patient.



(2) Discontinuing the record of issue referred to in paragraph 1 shall in the centralized repository

electronic prescriptions be abolished and it is possible to implement new

issue.



(3) cancellation of a record on the issue is sent through the information

the system of the issuing pharmacist central store of electronic

recipe markup language format, stating the reason for that is

a record of the issue dropped.



(4) the cancellation of a record on the issue is in a central repository

electronic stores in the form of mark picking recipes for the cancelled and

a central repository of electronic recipes will send the information immediately

the system of the issuing pharmacist a confirmation of the cancellation of a record

picking.



section 16 of the



Access to electronic prescriptions issued by a pharmacist and to those

electronic prescriptions on the basis of the medicinal products have been already

released



(1) a pharmacist through its information system accesses the

electronic prescriptions that are stored in a central repository of electronic

recipes using electronic identification marks referred to in the

the electronic prescription and electronic identification of medicinal

products that have been issued by the issuing pharmacist.



(2) Lékárníkmápřístup to electronic prescriptions,



a) on the basis of issued through the information system of the active

products, posted by their release the record to a central repository

electronic prescriptions, and has stored their electronic identification

characters,



(b)) to which he gave the patient electronic identification signs.



§ 17



Communication with a central electronic repository for pharmacist, recipes and

technical documentation to issue, on the basis of

electronic prescribing



(1) the pharmacy information system with a central electronic repository

recipes communicates through software communication adapter.

Electronic communication between the pharmacist and the hub

electronic prescriptions takes place in a secure manner, with the



and all data sent) central repository of electronic recipes

are signed by electronic signature,



(b)) all data received from the central store of electronic recipes

are signed by electronic signature,



(c)) the data or the communication channel is encrypted.



(2) each time you access the pharmacist to a central repository

electronic prescriptions is a repository to satisfy the his access permissions.



(3) a record of the issue, the change request, cancel the electronic prescription and

all other data are established and a central repository for advice

electronic prescriptions sent in the format of the markup language.

A central repository of electronic recipes always confirms the sending

hand receipt and store the data in this store.



(4) all communications and data transmitted between the pharmacist and the Central

electronic storage of recipes are recorded in the register of records

the inputs and the activities of the central store of electronic prescriptions (hereinafter referred to as

"the register"). In particular, shall be recorded in the register.



including the receipt of the request) sent data, identification of the consigning

pharmacist, date and time of receipt of the request, and any other needed

information related to the request,



b) send data from a central repository of electronic prescriptions,

identification of the pharmacist, the data being sent, the date and time of receipt of the request and

any other necessary information related to sending data.



(5) the technical documentation for the supply of medicinal products on the basis of

electronic recipe is published in electronic form in

the information resource of the State Institute for drug control, and it contains



and) format specification markup language interface all the necessary

documents for the prescription, including the definition of schemas for validation

documents in the format of a standard Extensible language-XSD and

documents for the validation of the format of the markup language,



(b) electronic identification marks) specification, including format,



(c)) detailed description of the communication with a central repository of electronic

recipes and adapter for communication,



d) specification of access security and traffic information

running a pharmacist and central repository of electronic prescriptions and

other necessary specifications.



(6) documentation in a central repository of electronic recipes records

for 5 years, which begins on the first day of the following

the calendar year after the calendar year in which it was to register in the

relation to this documentation made the first record. In relation to the

electronic prescriptions that have been exposed to him, has the documentation

in the central store of electronic prescriptions and patient access; for

electronic communication between the patient and the hub

electronic prescriptions, the provisions of paragraphs 1, 2 and 5 as appropriate.



§ 17a



The registry entry for medicinal products with restrictions



(1) where a medicinal product is to be delivered with the restriction, the pharmacist verifies whether the

the conditions for preparation or issue of such medicinal

of the product.



(2) verify the implementation of training or supply medicinal

of the medical prescription or medicinal product with the

content of cannabis for medicinal use does the pharmacist through

its information system in the registry for medicinal products with restrictions

so that the identification of the electronic character of the recipe with the prescribed

medicinal product. In the case of a medicinal product without a

Regulation with the limitation, the identification number of the insured person, unless the

public health insurance, the insured person's name, last name and date

the birth of natural persons.



(3) the pharmacist for access to the registry of medicinal products with a constraint

It uses the same login as for the communication with the Central

electronic storage of recipes. For communication with the registry for

preparations with the restrictions of section 13 to 16 shall apply mutatis mutandis. Through

the registry for the restricted medicines pharmacist turnover

communicated, whether the conditions for the preparation or medicinal

the product with the limitations.



(4) if the conditions for the realisation of a medicinal preparation

preparation of cannabis for medicinal use, the pharmacist shall take into

registry for medicinal products with a restriction to undertake the preparation of the record,

that contains the



and the prescribed cannabis for) the type of treatment used and its code according to

the legal rules relating to the conditions of issue and use of the prescription,

cannabis for medicinal use,



(b) the quantity of hemp) for therapeutic use in the upcoming medicine

of the product,



(c)) date of commencement of the preparation and



(d) the preparation of the pharmacist and) identification identify the Pharmacy where

preparation made.



(5) if the conditions for the realisation of the supply of the medicinal product

on medical prescription or medicinal product without a

Regulation with the restrictions, the pharmacist shall make to the registry for medicinal products

by limiting the record on the implementation issue according to § 13.



section 17b



Communication with the registry for a pharmacist to medicinal products with restrictions and

the technical documentation



(1) a pharmacist is communicating with the registry for medicinal products with restrictions

through software communication adapter. Electronic

communication between the pharmacist and the registry for medicinal products with restrictions

takes place in a secure manner, with the



and) all the data sent to the registry for medicinal products with restrictions

they are signed by a recognized electronic signature,



(b)) all data received from the registry for medicinal products with restrictions

they are signed by a recognized electronic signature and



(c)) the data or the communication channel is encrypted.



(2) every time you approach a pharmacist for medicines to the registry with

the registry is verified by its access permissions.



(3) communication pharmacist with the registry for medicinal products with restrictions

including all traffic data related to the issue of being in the format

markup language. Through the registry for medicinal products

by limiting the sending side is always confirmed receipt and store data.




(4) all communications and data transmitted between the pharmacist and the registry for

medicinal products with restrictions are recorded in the register of records

the inputs and the activities of the registry for medicinal products. This

the register contains



including the receipt of the request) sent data, identification of the consigning

pharmacist, date and time of receipt of the request, and any other needed

information related to the request,



b) send data from the registry for the restricted medicines, sent

data, date and time of data submission and any other necessary information

related to sending data and



(c) adoption of the report of the issuing pharmacist) about implementation issues, including

the data sent, in the case of preparation of a medicinal product containing cannabis

for the therapeutic use of reporting pharmacist start cooking, identification

consigning pharmacist, date and time of receipt of a report and, where appropriate, other

the necessary information related with the adoption of the Declaration.



(5) the technical documentation relating to the supply of medicinal products with the

limitations and the communication with the registry for medicinal products is restricted in

electronic format, published by the Institute in a manner allowing remote

access, and includes



and) format specification markup language interface all the necessary

the documents, including the definition of schemas for validation of documents in a format

standard Extensible language-XSD and for validation of documents

the format of the markup language,



(b)) a detailed description of the communication with the registry for medicinal products

restrictions and adapter for communication and



c) specification of the transmitted data and access security information

running the registry for pharmacist medicines with restrictions and additional

the necessary specifications.



section 18



Mail order picking



(1) mail order picking ^ 21) is ensured by suitable technical means and

in a way that will ensure the availability of information about mail order picking and

medicinal products to persons using mail order picking. Start and

implementation of mail order is subject to the issue by introducing and maintaining

system for the collection, processing and communication of information on

suspected serious or unexpected adverse reactions

preparations.



(2) a pharmacy to ensure mail order picking



and) is equipped with a means of communication to provide information

services,



(b)) provides the conditions of carriage according to the nature of the medicinal product and

circumstances, in particular the external temperatures, so that they are in accordance with the

the terms listed in the summary of product characteristics; in the event of contractual

ensure carriage of medicinal products in the other person's pharmacy in

Agreement shall negotiate the right to monitor compliance with the traffic for this person

conditions,



(c)) shall ensure that the documentation of the activities linked to the picking and shipping

the retention of this documentation in accordance with section 22.



(3) medicinal products, their prices and costs associated with

mail-dispersing ^ 22) contains at least the name of the medicinal product in accordance with

the decision on registration, including the code allocated to the State Institute for

drug control or the Institute for State control of veterinary

Biologicals and medicaments, strength and package size, farmakoterapeutickou

the group, the delivery terms.



(4) to ensure the mail order Pharmacy dispensing shall indicate in the notice ^ 23) name

pharmacies, including its address, the date of commencement of activities consisting in the

implementation of mail-order picking, or its termination or suspension.

In addition, the name, or name and last name of the pharmacist or

pharmaceutical Assistant providing information services, telephone

links to information services, including the address of the website.



(5) in the case of mail order supplying medicinal products abroad

It removes the foreign pharmacy marked medicinal products from a Distributor and

It is kept separate from other medicinal products.



§ 19



(1) the dispensing of medicinal products on the requisition confirming the person

requisition issued, where appropriate, the person in charge of the takeover, issued

of medicinal products by his signature. Provider of health services,

whose part is issuing a pharmacy, the standard operating

procedure to specify a different method of confirmation of the acceptance of medicinal products.



(2) for the transport of magistral formulae for gene

group therapy or medicinal products injectable anti-cancer agents

or authorised medicinal products group of anti-cancer agents can be

only used sealable means of transport, which is

protects against deterioration and the surrounding environment from pollution.

The means of transport must be marked with the warning "gene therapy" or

"Cytotoxic" according to medicinal products transported. Similarly,

proceeds in the case of other medicinal products affecting significantly

human health and the environment.



(3) any medicinal product prepared in a pharmacy that contain venena or

separanda, except medicinal products in which venena or

separanda used as antimicrobial medications for regular ingredient shall not be issued without

a prescription.



(4) the medicinal products shall be issued after the adjustment made to providers

health services in appropriate containers, having regard to the nature of the medicinal

of the product and type of treatment so as to not to compromise their quality.



section 20



Medicinal products containing narcotic drugs or psychotropic

the substance



(1) medicines containing narcotic drugs or psychotropic

substance ^ 12) shall not be issued without a prescription, or repeatedly on one

the recipe, if it is not a medicinal products which can be used, according to

the decision on registration, medical prescription or without

a prescription with a constraint.



(2) Medicinal preparations containing narcotic drugs or psychotropic

substance ^ 12) may, if they are issued on the requisition, take only a doctor,

veterinarian or health care professional designated for this purpose

a natural or legal person authorized to provide health

care ^ 5).



(3) the issue of medicines containing narcotic substances or

psychotropic substances ^ 12) proceed pursuant to section 10 and 11; by

are without prejudice to obligations laid down in other legislation ^ 24).



section 21



The storage of medicinal products, active substances and excipients



(1) the active substances and excipients shall be kept under the conditions laid down

by the manufacturer, the upcoming medicinal products shall be kept under conditions

established technological regulations or a person who is prepared,

and authorised medicinal products shall be kept in accordance with the terms of

listed in the summary of product characteristics, or according to the manufacturer's instructions.

Compliance with the temperature set for the storage of medicinal products,

active substances and excipients are continuously checked.



(2) medicinal products, active substances and excipients unsatisfactory

quality, after the time of their application, stored or

prepared for other than the prescribed conditions, obviously damaged or

unused, must be marked accordingly and kept at the Pharmacy

separately from other medicinal products, active substances and excipients

substances.



(3) in the case of downloading, the medicinal product of circulation at the request of Pharmacy

marketing authorisation holders and distributors provides

information about the progress of the download.



(4) the narcotic drugs and psychotropic substances ^ 12) must be maintained in accordance

with other legislation ^ 24). Active ingredients and auxiliary substances listed

between venena must be kept separate, lockable cupboards.

Separanda is retained in the Prep room drugs separately from other

medicinal products, active substances and excipients.



(5) the investigational medicinal products shall be kept under the conditions laid down

by the manufacturer or by the sponsor of the clinical trial; must be kept

separately from other medicinal products in a manner allowing to distinguish

medicinal products from individual clinical trials.



section 22



Documentation



(1) the activities in a pharmacy that is associated with the receipt and storage of medicinal

medicinal products, active substances and Excipients, preparation or treatment of

medicinal products, including their monitoring, and dispersing the healing

preparations must be documented, in paper or electronic

form. If the activities documented standard operating procedures

or technological regulations, exercise, in accordance with the following

documents.



(2) Documentation in a pharmacy make up



and records)



1. the acceptance of medicinal products, including their release and assigned codes

The State Institute for drug control, or the Institute for State control

Veterinary Biologicals and medicaments, medicinal substances, excipients and

medicinal products prepared in a different pharmacy; for such an acceptance test to

the taking of medicinal products from other pharmacies in pharmacy

the conditions laid down in § 82 para. 4 of the law on pharmaceuticals,



2. turbocharging of the active substances and Excipients,



3. sterilization and packaging of medicinal products, items and equipment,



4. check the received active substances and Excipients,




5. the preparation and control of medicinal products prepared in bulk, including

records for the release of each batch of medicinal products prepared

bulk over 20 packs; These records shall be signed by the head of a pharmacist or

a person authorized by,



6. check the prepared pure water and water for injection,



7. the prescribed inspection apparatus



8. prescribed check the space is determined by the purity of the air,



9. complaints, due to quality defects, withdrawals of medicinal products

out of circulation and information about suspected serious or unexpected adverse

effect and other facts relevant to the health of the people related

with the use of the medicinal product,



10. dispensing of medicinal products to providers of health care services on the

requisitions,



11. send electronic information to a central repository of electronic

recipes by picking the medicinal product on the electronic

recipe,



12. the provision of an authorised medicinal product other pharmacy at

the conditions laid down in § 82 para. 4 of the law on pharmaceuticals; These records

contain an indication of the lot of the medicinal product and of the allocation of the State code

Institute for drug control, or the Institute for State control

Veterinary Biologicals and medicaments,



13. check the integrity of the safety box for preparation of medicinal

preparations containing cytotoxic compounds; This check is performed

Once a week,



14. check the integrity of the safety box for preparation of medicinal

medicinal products for gene therapy and control of sanitation carried out after preparing

These medicinal products for an individual patient; This check is

performed once a week,



15. the temperature of the storage of medicinal products, active substances and excipients

substances,



(b)) offer authorised medicinal products for the purposes of mail order

the picking



(c) orders) and accompanying documents to the issue regards,



d) recipes for medicines fully paid for by the patient and to the active

preparations for the treatment of the animals,



e) technological regulations



f) standard operating procedures related to the preparation and control of

medicinal products, storage and dispensing of medicinal products, including

mail order picking, and for processing and transmission of information on suspect

the side effects,



g) evidence of narcotics and psychotropic substances ^ 24),



h) hygienic and sanitation regulations,



I) other documentation relating to the preparation and treatment of medicinal

products and operation of pharmacies, including regulations, work,

proof of education or persons handling medicines and the credentials to represent the

the head of the pharmacist by another pharmacist ^ 25),



j) recipes and requisitions on medicines containing narcotic substances and

psychotropic substances ^ 12)



k) inventory, receipt and issue of the medicinal products referred to in

the individual items it possible to distinguish the pharmaceutical form, the amount of

active substance contained per unit of weight, volume, or drive drug

the form and the size of the packaging of the medicinal product, for the authorised

products, including the code of the State Institute for drug control

or the Institute for State control of veterinary Biologicals and medicaments,



l) evidence regarding supply of the medicine without a prescription with

restrictions to identify the person to whom the medicine

issued; This evidence includes the name and surname of the person to whom the

the product is issued, the number assigned to the health insurance company, which is

by the insured person, or date of birth, if it is not insured, and a short record

the State of health of the person, that medicinal product was issued, including the

the record of the interview with him, which should be in the range

strictly necessary for the assessment of indications,



m) records associated with the replacement for the withdrawn medicinal products

to identify the medicinal product to replace with an indication of its

the code allocated to the State Institute for drug control, or the Institute for

State control of veterinary Biologicals and medicaments and lot number;

the evidence also includes a brief record of the reason for the download date

to perform an Exchange and a record of the submission withdrawn medicinal products

According to § 89 paragraph 1. 1 or 3 of the law on medicinal products.



(3) technological prescription dated and signed by the head of

pharmacist, or by an authorised another pharmacist ^ 25), contains a procedure

preparation of the medicinal product, its composition, including the quantity of the active substance

unit of weight or volume, the destination of the packaging material, method of

the description and conditions of storage, as well as the procedures for carrying out checks

preparation, including the extent of the checks, indicating the values, which has

be achieved, and shelf life. Technological measure continuously

updates, changes that you make are characterized by so as to preserve the original

the text dated and signed by the head of the pharmacist. On the technological

Regulation of the use of the surplus is characterized by its expiry date

and the signature of the head pharmacist. If the European Pharmacopoeia ^ 26)

or the Czech Pharmacopoeia contains the provisions relating to authorised

product or technological provision, these provisions in the

technological regulation into account. Technological prescription may be maintained

as well as in electronic form. In this case, the head of the pharmacist shall ensure

their regular updating.



(4) the dossier, whose registration is not governed by other legislation ^ 27),

including orders and the accompanying documents to the issue, with regards

kept for at least 5 years from the date of the last entry or

mail order picking.



(5) the documentation of investigational medicinal products at the drugstore make up

records records of receipt and issue of investigational medicinal products, including

records on the conditions of storage of investigational medicinal products.



PART THREE



PREPARATION OF RADIOPHARMACEUTICALS AND TRAFFIC CONDITIONS IN THE WORKPLACE

NUCLEAR MEDICINE



Article 23 of the



Principles for the preparation of radiopharmaceuticals



(1) in the preparation of radiopharmaceuticals shall comply with the principles of good laboratory

practice referred to in sections 3 to 6 and section 7 (b). and) adequately. Radiopharmaceuticals are

preparing for the workplace of the holder of the authorisation to management of resources

ionizing radiation under other legislation ^ 28).



(2) the Radiopharmaceutical is



and prepared according to technological regulations) or standard

operating procedures, in which the rules are taken into account for the handling of

with radioactive substances), ^ 7 ^ 27), and according to the



1. The Czech Pharmacopoeia,



2. summaries of product characteristics and package leaflet in the case

authorised medicinal products, or



3. the procedure approved in the context of a clinical trial,



(b) control and wit the) technological regulations or

standard operating procedures referred to in subparagraph (a)).



(3) If, in the preparation of radiopharmaceuticals shall apply the blood components or other

biological material removed from the patient, can be prepared

radiopharmaceuticals used only for the patient, from which it was made.



section 24



Workflows



(1) in the preparation of radiopharmaceuticals are no more different

radiopharmaceuticals in one place ^ 7). Preparation of radiopharmaceuticals when

recovery of components of blood or other biological material shall be made

on the space provided for this purpose only.



(2) if the prepared radiopharmaceutical transported, shall be

under another law ^ 29).



(3) the Radiopharmaceuticals, which have not been used, after the expiration of their

usability considered radioactive waste and is with them and according to

usage ^ 7).



§ 25



Labelling of radiopharmaceuticals



(1) the inner packaging of radiopharmaceuticals prepared before the release of marks

the label, which is given the name, the chemical symbol of the radionuclide,

the quantity in millilitres with total activity, the name or names and

last name that wrote the date and hour. In a similar manner and marks

the outer packaging. If the issuing the radiopharmaceutical in the syringe to

the individual patient, in his name, or the names of the first and last name

or otherwise unmistakable way.



(2) a radiopharmaceutical is attached to the pending passport, which in addition to

the data referred to in paragraph 1 also contains



a) method of administration,



(b)) the name, or first and last name of the person who carried out the inspection

the prepared radiopharmaceutical.



section 26



Documentation



(1) a workplace to provide Documentation of the radiopharmaceutical consists of



and records)



1. reception of radio-nuclide generators, radio-pharmaceuticals, or medicinal substances

and auxiliary substances,



2. the preparation of radiopharmaceuticals,



3. check the prepared radiopharmaceuticals,



4. the control of devices and equipment for the preparation and evaluation of the quality

radiopharmaceuticals,



5. the results of the monitoring of the workplace ^ 7),



6. the issue of radiopharmaceuticals,



7. management of radioactive waste ^ 7),



8. complaints due to defects in quality and the download of the medicinal

products from circulation,



(b) regulations or) technological standard operating procedures referred to in §

23 para. 2 (a). and (3))



(c)) evidence of radioactive materials ^ 7),



d) operating, sanitation and an internal emergency plan

.



(2) documentation of sites serving radiopharmaceuticals is included in the


paper or electronic form. If her evidence does not control other

^ Law 27), including orders, shall be kept for at least

period of 5 years from the date of the last entry.



section 27 of the



Review



(1) before issuing the radiopharmaceutical prepared to verify its quality according to §

23.



(2) to be checked, use the apparatus and equipment, whose eligibility

to measure has been verified under other legislation ^ 30).



(3) the site at which they prepare radiopharmaceuticals, monitors

under another law ^ 7).



section 28



Special provisions



(1) the premises and facilities for the preparation of radiopharmaceuticals governing other legal

^ 7) regulations.



(2) for the cleaning of premises and equipment in the workplace of radiopharmaceuticals,

processes a standard operating procedure, which includes the frequency

the individual sanitation work.



(3) in the event of radiological accident or incident shall

According to the internal emergency plan of the workplace, the instructions of the responsible

person ^ 31) and other legislation ^ 32).



PART FOUR



PREPARATION OF HUMAN VACCINES AND MORE AUTOGENNÍCH TERMS OF

WORKPLACES TAKING THEIR PREPARATION



section 29



Preparation and checking of vaccines for human autogenních



(1) in the preparation of human vaccines, the autogenních shall comply with the principles of

good laboratory practice referred to in § 3 to 7 as appropriate.



(2) Human autogenous vaccines are prepared on the basis of medical

prescription for an individual patient under the drawn up by technological

prescription. The responsible person ^ 31) is responsible for the observance of technological

How to prepare and is responsible for the quality, efficacy and safety

autogenous vaccines.



(3) as a raw material for the preparation of vaccines will be used for human autogenních

pathogens or antigens collected from the patient for whom it is

the vaccine is intended.



(4) in the case of vaccines for human autogenních check is made in accordance with § 9

adequately. The control of biological tests are carried out according to the nature and

the method of preparation of Autogenous vaccines and the technological

legislation.



section 30



Labelling and documentation



(1) in the labelling of human vaccines in addition to the requirements of the autogenních

referred to in § 8 para. 2 (a). (e)), f), (g)), h), k), (l)) and o) and § 8 para. 3

further indicating that human autogenous vaccine has prepared, and

the method of administration.



(2) Documentation in the workplace in preparation of human autogenous vaccines

make up the



and prescription)



(b)) record



1. collection,



2. your own preparation, including dilution,



3. check



4. storage and delivery,



5. periodic inspection according to § 3 (2). 2 (a). (f)),



c) standard operating procedures documenting



1. the collection,



2. control,



3. storage and picking



4. operational, hygiene and sanitary regulations,



(d) the rules of technology, documenting the preparation) of human autogenních

vaccines in accordance with § 22 para. 3.



(3) in the preparation of human vaccines, the autogenních, in addition to the activities

referred to in paragraph 2, the document and the activities associated with the collection of the

pathogens or antigens.



(4) the dossier is registered under section 22 by analogy.



PART FIVE



PICKING CONDITIONS IN THE INSTITUTIONS OF PUBLIC HEALTH



section 31



Dispensing of immunological products



(1) public health authorities issued immunologicals

(hereinafter referred to as "vaccines") for the purpose of vaccination of natural and legal persons

authorized to provide health care under another law ^ 33)

According to the annual plan of vaccines in the case of vaccines, with the exception of vaccines

rabies, tetanus when injuries and healing wounds, against

Tuberculosis and tuberculin ^ 34).



(2) the employee with professional qualification for working in health care in

authority to protect public health ^ 5)



and according to the annual plan) issues of vaccines provided for amount and type of vaccine

the basis of the order of natural or legal persons authorized to provide

health care,



(b)) at the time of verification of the quantities, type, package, batch number and time

the applicability of the vaccine; If the vaccine is not available in the requested

the size of the package, the other package size in the appropriate number of

the benefits and the change shall be recorded in the order; acknowledge his signature issue and

identification of the authority to protect public health,



(c) before issue of vaccine) checks whether the ready for shipment

packaging that ensure compliance with the temperature specified by the manufacturer; If they are not

These packages are ready, the vaccine will not issue.



(3) the employee of natural or legal persons authorized to provide

health care authorized to receive the vaccine the vaccine to its takeover confirmed

the signature on the original transcript and order.



§ 32



Storage of vaccines



The vaccine is kept under the conditions referred to in the summary of

the product, in accordance with the terms of the specific treatment programs

where appropriate, in accordance with the manufacturer's instructions. Compliance with the temperature is checked

the unit documenting compliance with a prescribed temperature range.

The provisions of § 21 para. 2 and 3 shall apply mutatis mutandis in the case of vaccines.



§ 33



Documentation of receipt, dispensing, and storage of vaccines



(1) the activity in the establishment of public health protection associated with dispersing,

reception and storage of vaccines, the documents. If the dossier is

conducted in electronic form, the data is backed up renewable way.

The documentation consists of



and records of taking delivery of the vaccines), including their lot and code,



(b)) order vaccines for the period presented by providers of

health services,



c) processed vaccines on a given period plans based on the demographic

the data of the relevant territorial unit, a valid vaccination schedule and

requirements for providers of health care services,



(d) records of the performed inspection) temperature range during storage

vaccines, and it at least once a day, and when transporting vaccines, with a

signature control performing employees



(e) the record of destruction) vaccines, including because of the destruction, the name,

where appropriate, the names and surname of the person who approved the destruction of species,

quantity, lot number and expiry date of the vaccine,



f) records for the complaints due to defects in quality or download the vaccine

out of circulation and information about suspected serious or unexpected adverse

effect and other facts relevant to the health of the people related

with the use of the medicinal product,



g) records of equipment,



h) inventory, receipt and issue of vaccines according to the individual

items possible to distinguish the pharmaceutical form, the quantity of the active substance

contained in the unit of mass, volume or unit dosage forms and

the size of the packaging of the vaccine, including code,



I) standard operating procedures for the receipt, distribution and storage of vaccines,



j) operational, hygiene and sanitary regulations.



(2) documentation is kept pursuant to section 26 paragraph 1. 2 accordingly.



PART SIX



CONDITIONS FOR THE HANDLING OF MEDICINAL PRODUCTS IN THE PROVISION OF HEALTH

SERVICES WITH THE EXCEPTION OF THE PROVISION OF PHARMACEUTICAL CARE



§ 34



Supply of medicinal products



The providers of health services supplied medicines pharmacy or

the operator of another workplace or equipment serving the healing

preparations. Blood transfusion products delivered to providers of health

device services transfusion services; gases used in the provision of

health services, advanced therapy medicinal products, rated

medicinal products, infusion, hemofiltrační and dialysis solutions and

immunological preparations for vaccination, they can be supplied also

wholesale distributors of medicinal products. Provider of health services

progresses in treatment with medicinal products, so as to ensure the

quality, safety and efficacy of medicinal products.



§ 35



Adjustment of the medicinal products



When you edit a medicinal health services provider is

proceed according to the summaries of the individual medicinal products,

the manufacturer or the contracting entity or clinical trials by

standard operating procedures, in which the conditions will apply

preparation in accordance with § 3 (1). 4 and 8, section 4, paragraph 4. 1, § 8 para. 4 and § 9 para. 7.



section 36



The retention of



(1) medicinal products shall be kept under the conditions referred to in summary

information about the product or the manufacturer's instructions, the supplying pharmacy or

workplace or equipment preparing medicinal products and shall apply

storage conditions pursuant to § 21, mutatis mutandis.



(2) any medicinal product prepared in a pharmacy shall be stored only in

original packaging.



(3) medicinal products shall be stored so as to preserve the data that

It identifies.



(4) the investigational medicinal products should be maintained according to the instructions of the manufacturer or

the sponsor of the clinical trial separately from other medicinal

preparations.



§ 37



Documentation



(1) activity associated with income, transportation, treatment, storage of medicinal

products and the use of medicinal products in the provision of health

services is documented. If the documentation is kept in electronic

the form, the data is backed up renewable way.



(2) Documentation form



and records)



1. reception of medicinal products,



2. the use and adjustment of the medicinal products in the provision of health

care,




3. the register of medicinal products in the workplace,



4. check the temperature of the storage of medicinal products, in the case of

medicinal products that require reduced temperature retention of records

carried out at least once a day,



5. complaints due to defects in quality and the download of the drug from circulation,



(b)) information about suspected serious or unexpected adverse reaction and

other facts relevant for the health of the people related to the

the use of the medicinal product,



c) standard operating procedures documenting to the extent appropriate

activities carried out by the



1. reception of medicinal products,



2. adjustment of the medicinal products,



3. use of medicinal products in the provision of health services,

including equipping patient medicines ^ 35),



4. the storage of medicinal products.



(3) the standard operating procedures are provided with the date and signature of the person,

that is in the selected site for the handling of medicinal products

responsible.



(4) the dossier is registered under section 22 by analogy.



§ 38



For the equipping of the patient ^ 35) may only be granted a medicine



and in the package) whose integrity is not impaired, or



(b) rigid or semi-rigid) split pharmaceutical forms; such a medicinal product

the product shall be provided, in the container tightly closed, on which shall be entered the name of the

of the medicinal product including strength and its manner of use and the conditions of its

the retention.



PART SEVEN



MEDICINAL PRODUCTS TO VETERINARIANS, RETENTION AND LEADERSHIP

DOCUMENTATION



§ 39



Issue



In the case that a veterinarian for treatment of the animal emits healing

preparations of animal breeders, performs a veterinarian and breeder,

which the medicinal product is released, the record on the issue. Veterinarian

instruct breeders about the dosage, mode of application and storage issued

of the medicinal product. For medicinal products which affect the behavior of

an animal or have set withdrawal period, and the time keeper will instruct

their duration and of the obligations that this entails.



section 40



The retention of



(1) the veterinarian shall keep the medicines in the manner specified in §

21, art. 1 to 3, even in transit, if the veterinarian

pursues a professional work outside of their doctor's Office.



(2) any medicinal product prepared in a pharmacy are kept only in the

original packaging.



(3) on the initiative of the Institute for State control of veterinary Biologicals and

of medicines, the marketing authorisation holders or distributors downloads

veterinarian medicines out of circulation in case of suspected

the occurrence of the adverse event or faults in the quality of the medicinal product. In

case of suspected quality defect for a medicinal product

the veterinarian shall inform the State Institute for drug control.



(4) medicines containing narcotic drugs or psychotropic

^ 12) substances shall be stored pursuant to § 21 para. 4.



§ 41



Documentation



(1) the activities associated with the collection and storage of medicinal, dispersing

medicines in veterinary surgeon, including their control, shall be

documented.



(2) Documentation form



and records)



1. acceptance of authorised medicinal products and medicinal products

prepared in the pharmacy,



2. complaints due to defects in quality and download drugs out of circulation and

information on the occurrence of a serious side effect of the medicinal product

or adverse reaction, which in the context of this

with a man, even in the case when this product

the product has not been used in accordance with the summary of product characteristics, the

used incorrectly or was misused,



3. dispensing of medicinal products farmers acquired in accordance with other legal

Regulation ^ 36),



4. check the storage condition of pharmaceuticals for veterinary surgeon,



(b)) evidence of narcotics and psychotropic substances ^ 12) according to another

^ Law 24),



c) blocks used recipes marked with a blue stripe and blocks used

requisitions marked blue stripe.



(3) documentation is kept in accordance with section 22 apply mutatis mutandis.



PART EIGHT



TRANSITIONAL AND FINAL PROVISIONS, THE CANCELLATION



§ 42



Transitional provision



For the active substances and Excipients, produced by the entry into force of this

the decree is carried out before applying them to each package in addition to the

an organoleptic examination pursuant to § 9 para. 6 as well as physico-chemical testing.



§ 43



Regulation (EEC)



Shall be repealed:



1. Decree No. 255/2003 Coll., which provides for the right of pharmaceutical

practice, more detailed conditions for the preparation and editing of the medicinal products, supply and

treatment with medicinal products in medical devices, and more

conditions for operation of pharmacies and other operators, of the issuing of the active

preparations.



2. Decree No. 220/2006 Coll., amending Decree No 255/2003 Coll.

laying down the right of pharmaceutical practice, more detailed conditions for the preparation and

adjustment of the medicinal products, supply and handling of medicinal products within the

medical facilities and further conditions of operation of pharmacies, and other

operators, of the issuing medicines.



3. Decree No. 6/2007 Coll., amending Decree No 255/2003 Coll.

laying down the right of pharmaceutical practice, more detailed conditions for the preparation and

adjustment of the medicinal products, supply and handling of medicinal products within the

medical facilities and further conditions of operation of pharmacies, and other

operators, of the issuing of medicinal products, as amended by Decree No.

220/2006 Sb.



§ 44



The effectiveness of the



This Decree shall take effect on the date of its publication.



Minister of health:



Mudr. Julínek, MBA in r.



Minister of agriculture:



Mgr. Gandalovič in r.



Annex 1



A DETAILED BREAKDOWN OF THE MEDICINAL FORMS WITH REGARD TO THE COMPOSITION AND THE ROUTE OF ADMINISTRATION

-------------------------------------------------- --------------------------------------------------------------------

The Latin name of a pharmaceutical formulation for detailed examples of medicinal products within the pharmaceutical forms

forms of

-------------------------------------------------- --------------------------------------------------------------------

Liquid and semi-solid Peroralia liquida et oral drops, oral solution, oral suspension,

oral preparations of semisolida oral emulsion, powder propřípravu oral solution

or suspension, granules for oral preparation

suspension, powder for oral solution, or

suspension with solvent, syrup, powder for syrup

granules for preparation of syrup, Tablet for the preparation

oral solution or suspension, medicinal tea, powdered

medicinal tea, oral gel oral paste,



Solid oral products Peroralia solida oral powder, effervescent powder, granules, sparkling spheres

powder enteric coated granules, granules

prolonged release granules with controlled

release, starch capsule, capsule, capsule, soft,

enteric coated capsule, enteric coated capsule, soft,

prodlouženýmuvolňováním capsule, hard, soft capsule

prolonged release, controlled release capsule, hard

release, soft capsule, Tablet, controlled-release tablets

coated tablet, film-coated tablet, effervescent tablet,

oral lyophilisate, gastro-resistant tablet, Tablet

modified-release tablets, prolonged-release tablet,

chewable tablet, oral gum, pill, intraruminální

the Insert for the pulse easing (vet), liz (vet), premix for

medicated feedingstuffs (vet), pellets



Oral preparations and Oromucosalia et Gargle, concentrate for gargles, powder for

preparations for use on the gingivalia preparation, for the preparation of Tablet gargles gargles, oral

gums, oral suspension, solution, oral drops, oral spray,

the sublingual spray, solution for oral rinses, tablets for

prepare the solution for oral rinses, solution on the gums, oral

gel oral paste, medicated chewing gums, gel, paste

on the gums, oral capsule, sublingual tablet, mukoadhesivní

bukání tablet, bukání tablet, lozenge



Dental preparations Stomatologica Dental gel, tooth bar, tooth powder, tooth, dental solution

suspension, emulsion, toothpaste dental



Preparations for skin and Dermatologica and an ingredient in baths, cream, gel, ointment, paste, skin mousse,

transdermal use transdermalia shampoo, skin spray solution, skin spray-suspension, skin

spray-powder, solution, concentrate for skin


the solution, skin, skin emulsion, suspension, skin powder, solution

for iontoforézu, a transdermal patch skin coating, healing

Nail Polish, kataplazmata, skin filled with stick

dressing means the collar (vet) medikovaný pendant

(vet), ear label (vet), soaking bath-solution (vet.)

soaking bath-suspension (vet.), soaking bath lotion

(vet), pouring on the back-the solution (vet.), pour-on

spine-emulsion (vet.), kapkyna skin-a solution or suspension

or emulsion (vet.), teat bath-soaking solution or

suspension or emulsion (vet.), spray on the teats-solution (vet.)



Eye preparations Ocularia eye cream, eye gel, eye ointment, eye drops, solution or

suspension, powder and solvent for the preparation of eye drops

in the solution, powder and solvent for the preparation of eye drops

in suspension, a solvent for the preparation of eye drops, eye

prolonged release drops, eye water, solvent for

preparation of the eye water, eye insert,



Ear preparations Auricularia Ear ear gel cream, ointment, ear, ear drops-the solution or

suspension or emulsion, ear, ear spray-powder solution or

suspension or emulsion, ear omývadlo-solution or emulsion,

ear swab, ear stick



Nasal products Nasal Nasalia cream, nasal gel, nosnímast, nasal drops-the solution or

suspension or emulsion, nasal, nasal spray-powder solution or

suspension or emulsion, nasal, nasal omývadlo rod



Vaginal preparations Vaginalia Vaginal cream, vaginal cream, vaginal, vaginal ointment

gel, vaginal foam, vaginal, vaginal suspension, solution

vaginal Tablet for preparing emulsion, vaginal solution,

vaginal ball, hard vaginal capsules, soft vaginal

Capsule, vaginal tablet, effervescent vaginal tablet, medicine

vaginal tampon, vaginal, vaginal insert hubka (vet.)



Rectal preparations Rectalia Rectal cream, rectal gel, rectal ointment, rectal foam,

rectal solution, rectal suspension, rectal emulsion,

concentrate for rectal solution of powder for

preparation of rectal solution, powder for rectal

suspension, Tablet for rectal solution preparation, Tablet

for the preparation of rectal suspension, suppository, rectal capsules,

rectal swab



Inhalanda inhaled medication nebuliser solution, suspension of spraying powder for

the suspension of spraying, emulsions for spraying,

inhalation solution tlakovémobalu, suspension for inhalation

in suspension, emulsion for inhalation glucocorticoid, powder

for inhalation, inhalation powder, hard capsules, inhalation powder

for inhalation, steam inhalation powder, solution

inhalation of steam, steam inhalation tablet,

ointment steam inhalation, inhalation fluid

steam, gas inhalation



Parenteral drug products Parenteralia solution for injection or the suspension or emulsion, powder for

solution for injection, powder for suspension or

solution for injection, powder for injection

injection solvent concentrate for

solution for injection, infusion, or emulsion,

powder for solution for infusion, powder for the preparation of

the infusion solution with the solvent, the solvent for

Parenteral use.



Implantata implants implant, implantation, implantation Tablet string



Preparations for dialysis Praeparata for dialysi Solution for peritoneal dialysis solution for hemofiltraci,

haemodialysis solution, concentrate for solution

for hemodialysis



Urethral and Uretralia et Solution into the bladder, the solution to rinse the urinary

preparations for use in intravesicalia bladder powder for přípravuroztoku to rinse of the urinary

bladder bladder, urethral gel, urethral Stamen



Tracheopulmonální Tracheopulmonaria a solution or suspension to endotracheopulmonální the installation,

products for the preparation of roztokuk powder endotracheopulmonální

installation, powder for solution

to install endotracheopulmonální with solvent



Endocervical Endocervicalia Endocervicální gel products, powder for the preparation of the endocervical

the solution with the solvent



Intramammary preparations Intramammaria (vet.) Intramammární a solution or suspension or emulsion, intramammární

(vet.) ointment, struková bar,



Intrauterine preparations Intrauteriaria (vet.) Intrauterine insert, intrautrinní solution, intrauterine

(vet.) suspension, intrauterine emulsion, intrauterine tablet,

intrautrerinní capsule

-------------------------------------------------- --------------------------------------------------------------------



Annex 2



CLASSIFICATION OF AIR CLEANLINESS FOR EACH CLASS BY THE NUMBER OF PARTICLES

+--------------------------------------------------- ---------------------------------------------+

| The maximum number of particles/m3 equal or greater |

| Class |

| For the rest (b) For traffic |

| |

| mikrom mikrom 0.5 0.5 5 mikrom 5 mikrom |

+--------------+-----------------+----------------+- ----------------------+----------------------+

| A | 3 520 | 20 | 3 520 | 20 |

+--------------+-----------------+----------------+- ----------------------+----------------------+

| | 3 520 | | | |

| (B) (a) | | 29 | 352 000 | 2 900 |

+--------------+-----------------+----------------+- ----------------------+----------------------+

| (C) (a) | 352 000 | 2 900 | 3 520 000 | 29 000 |

+--------------+-----------------+----------------+- ----------------------+----------------------+

| (D) (a) | 3 520 000 | 29 000 | undefined (c) | undefined (c) |

+--------------+-----------------+----------------+- ----------------------+----------------------+



Notes



(a) in order to achieve the requirements of the class, (B), (C) and (D), the air exchange rate

adapted to the size of the room, placed the device in it and the number of

workers in the room. Ventilation should be provided with the appropriate

filters, such as HEPA for classes A, B and C.



(b) the Limit for the maximum number of dust particles in an "idle"

corresponds to ISO classification, as follows:



Class, and corresponds to ISO 4.8 when the limit for particle size > = 5.0 mikrom,

class B corresponds to ISO 5. Class C corresponds to ISO or ISO 7 and 8 class

(D) corresponds to ISO 8.



(c) the requirements and limits for this class are dependent on the nature of

operations are carried out.



1) section 11 (b). d) of Act No. 378/2007 Coll., on pharmaceuticals and on changes

certain related laws (law on medicinal products).



2) section 11 (b). (b)) Law No 378/2007 Sb.



3) § 79 paragraph 2. 8 (a). and) Act No. 378/2007 Sb.



4) § 25 para. 1 of law No 378/2007 Sb.



5) Act No. 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.



Law No. 96/2004 Coll., on conditions for the acquisition and recognition of eligibility for

the exercise of paramedical professions and to pursue activities

related to the provision of health care and on amendments to certain

related laws (the law on the paramedical professions),

in the wording of later regulations.



6) section 69 of the Act No. 378/2007 Sb.



7) Decree No 307/2002 Coll., on radiation protection, as amended

regulations.



8) § 3 (1). 1 of law No 378/2007 Sb.



9) § 8 para. 3 of the law No 378/2007 Sb.



10) section 49 of Act No. 378/2007 Sb.



11) § 51 of Act No. 378/2007 Sb.



12) Annex 1 and 5 of the Act No. 167/1998 Coll., on substance abuse and

amendments to certain other laws, as amended.



13) Law No 350/2007 Coll., on chemical substances and chemical mixtures and

amending some laws (legislation).



14) section 39 of Act No. 378/2007 Sb.




15) Decree No. 54/2008 Coll., about how the prescription of medicinal

products, information to be entered on the medical prescription and the rules

the use of prescriptions.



16) Act No. 48/1997 Coll., on public health insurance and amending and

certain related laws, as amended by the Act No. 261/2007

SB.



Decree No. 54/2008 Sb.



17) § 39 para. 3 of the law No 378/2007 Sb.



18) § 82 para. 1 of law No 378/2007 Sb.



19) section 15 of Decree No. 54/2008 Sb.



21) section 84 and 85 of law No 378/2007 Sb.



22) § 85 para. 2 of law No 378/2007 Sb.



23) § 84 paragraph. 3 of the law No 378/2007 Sb.



24) Act No. 167/1998 Coll., as amended.



25) § 79 paragraph 2. 6 of law No 378/2007 Sb.



26) section 11 (b). (c)) Law No 378/2007 Sb.



27), for example, Act No. 18/1997 Coll. on peaceful uses of nuclear energy

and ionizing radiation (the Atomic Act), and amending and supplementing certain

laws, as amended, Act No. 258/2000 Coll., on the protection of

public health and amendment to some related laws, as amended by

amended.



28) Act No. 18/1997 Coll., as amended.



29) Law No 111/1994 Coll. on road traffic, as amended

regulations.



30) Act No. 506/1990 Coll., on weights and measures, as amended.



Decree No 345/2002 Coll., which provides for the gauge to a compulsory

authentication and gauges subject to type-approval.



31) § 79 paragraph 2. 7 of law No 378/2007 Sb.



32), for example, Act No. 18/1997 Coll., as amended,

Decree No 307/2002 Coll., as amended, Decree No.

49/1993 Coll., on technical and material requirements for equipment

medical devices, as amended, Decree No.

318/2002 Coll., on details to ensure emergency preparedness

nuclear facilities and workplaces with sources of ionizing radiation and

the requirements for the contents of the internal emergency plan and emergency procedure, in

amended by Decree No. 2/2004 Sb.



33) Act No. 258/2000 Coll., on the protection of public health and amending

some related laws, as amended.



34) Decree No. 537/2006 Coll., on inoculation against infectious diseases.



35) § 5 para. 8 of law No 378/2007 Sb.



36) Decree No 325/2003 Coll., laying down rules for the application of

medicinal products in providing veterinary care, including

related prescription and dispensing of medicinal products and the requirements for

keeping a record of those activities, and requirements for notification of the loading

with some substances or preparations, including the conditions for the management and

keeping a record of these activities.



37) Decree No 226/2008 Coll., on good clinical practice and detailed

the conditions of the clinical evaluation of drugs.