Decree No. 54 / 2008 Coll.
Ordonnance on the method of prescribing medicinal products, the particulars on the prescription and the rules on the use of the prescription
Valid
Order
Effective from 25.02.2008
54
DECLARATION
of 6 February 2008
on the procedure for prescribing medicinal products, the particulars referred to in the prescription and the rules on the use of the prescription
The Ministry of Health, after consulting the Ministry of Agriculture, the Ministry of Defence, the Ministry of Interior, the Ministry of Justice and the Ministry of Finance, according to § 114 (3) and to implement § 80 of Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines):
GENERAL PROVISIONS
Preliminary provisions
(1). This decree lays down the procedure for prescribing medicinal products, the particulars given on the prescription and the rules on the use of the prescription.
2). For prescribing medicinal products, doctors use medical prescription1),
(a) prescription recipes
1. medicinal products containing narcotic substances included in list I2 (hereinafter referred to as "narcotic substances") or psychotropic substances listed in list II3 (hereinafter referred to as "psychotropic substances") which are marked with a blue stripe; the model of this recipe is set out in Annex 1 to this Decree,
2. medicinal products for human use, with the exception of those referred to in point 1, for the purpose of providing health services, including for their re-supply in accordance with Article 6 (4);
3. veterinary medicinal products and medicinal products for human use, with the exception of those referred to in point 1, for the purpose of providing veterinary care, including for the re-supply referred to in Article 6 (4),
(b) orders from health service providers (hereinafter referred to as "the provider") and natural or legal persons authorised to carry out veterinary activities (5), for medicinal products, including transfusion products, with the exception of medicinal products referred to in point (a) (1) ("vouchers");
(c) applications for medicinal products referred to in (a) (1) which are marked with a blue stripe; the model of this request is set out in Annex 2 to this Order.
(3) For the prescription of medicinal products, use of
(a) a recipe in electronic form (hereinafter referred to as the "electronic recipe") sent by the prescribing physician to the central repository of the electronic recipes (6) signed by a recognised electronic signature of the prescribing physician under another legislation7 (hereinafter referred to as "electronic signature"); or
(b) a request in electronic form (hereinafter referred to as "electronic request") sent by the prescribing doctor and bearing a verification code assigned by the provider, if it is sent within the local computer network of this medical facility to the pharmacy which is part of it; or signed by electronic signature when sent to a pharmacy outside that local computer network,
provided that they comply with the requirements of § 6 or 13.
(4) The medical prescription and the extract from the recipe shall not contain characters or elements which restrict the legibility of the data supplied by the provider or which are of an advertising nature.
(5) A medical prescription, with the exception of a prescription marked with a blue stripe, may be applied against its misuse by protective devices.
Treatment of medical regulations
Medical regulations shall be imposed in such a way as to prevent their loss or theft and the possibility of their misuse. Uncompleted medical provisions may not be stamped by the provider, natural or legal persons authorised to perform professional veterinary activities (5).
Treatment of medical regulations marked with a blue stripe
(1) The production and distribution of medical prescriptions marked with a blue stripe is ensured by the local competent municipal authorities with extended competence with the contracted manufacturer of such forms, on the basis of orders from providers or natural persons or legal persons authorised to perform professional veterinary activities (5) (hereinafter referred to as authorised persons) with the place of performance of those activities in the administrative districts of the municipal authorities with extended activity (8).
(2) In order to ensure the smooth distribution of medical prescriptions marked with a blue stripe, municipal authorities of municipalities with extended coverage of their emergency supply shall create a maximum of one fifth of their total distribution for the previous calendar year.
(3) The medical regulations marked with a blue stripe contain the particulars according to the models set out in Annexes 1 and 2 to this Decree and are taken from the manufacturer by an authorised staff member of the municipal office of the municipality with extended competence. The authorised staff member shall prove to the manufacturer when taking over the prescribed medical prescriptions by delegation and shall confirm receipt by signature and stamp of the municipal office of the municipality with extended scope.
(4) The municipal authority of the municipality with extended scope of medical regulations marked with a blue stripe after taking over shall register and invite the authorised person to pick them up. Medical regulations marked with a blue stripe may be issued only to authorised persons or their authorised representatives by the municipal authorities of the municipalities with extended competence.
(5) The municipal authority of the municipality, with extended scope, shall keep a paper containing information on the number of medical prescriptions issued, including their serial numbers and identification of the authorised person, on the issue of the medical regulations marked with the blue stripe. The authorised person or his authorised representative (8) shall confirm the receipt of the medical prescription marked with the blue stripe on the original order and the signature in the form book.
(6) The loss or theft of an uncompleted prescription, marked with a blue stripe, shall be notified without undue delay to the municipal authority of the municipality with extended scope, which issued these forms to the authorised person, and the loss or theft shall also be notified to the police of the Czech Republic.
(1) Where authorised persons issue medical provisions marked with a blue stripe to persons who are in employment or in a similar relationship, the authorised person shall keep a record of such expenditure in accordance with Article 3 (5).
(2) Impaired or unnecessary medical prescriptions marked with a blue stripe, including their signatures, shall be handed over to that person by the person to whom those medical prescriptions have been issued by the authorised person.
(3) The authorised person shall keep a record of the medical rules marked with a blue stripe, including their signatures, which have been discarded or unnecessary. Such medical rules shall be transmitted by the authorised person to the local competent municipal office of the municipality with extended scope for liquidation. This municipal authority shall draw up a record of the liquidation of the medical prescription marked with a blue stripe, including the endorsements thereof, confirming their receipt from the authorised person.
(4) The medical regulations marked with a blue stripe, including their signatures, returned to the municipal authorities of the municipalities with extended scope shall be kept in the register by the local authorities.
(5) Article 2 shall apply mutatis mutandis to the treatment of medical regulations marked with a blue stripe.
(6) The medical regulations marked with a blue stripe are issued by the Ministry of Defence to authorised persons under the responsibility of the Ministry of Defence with its code. Paragraph 3 (3) to (6) and paragraphs 1 to 5 of this provision apply to the treatment of these medical provisions, with the Ministry of Defence providing the activities entrusted to the local municipal authority of the municipality with extended competence. The loss or theft of medical prescriptions marked with a blue stripe shall be reported to the appropriate military medical authority and military police.
PRESENTATION OF MEDICINAL PRODUCTS FOR THE PURPOSE OF PROVISION OF VETERINARY HEALTH
Method of prescription
(1) One prescription can be prescribed
(a) one type of medicinal product containing narcotic substances or psychotropic substances; or
(b) a maximum of two types of other medicinal products.
(2) When prescribing medicinal products, the number of packages or doses shall be indicated by Roman numerals and words in Latin.
(3) Medicinal products containing narcotic substances or psychotropic substances are prescribed for recipes marked with a blue stripe.
(4) When prescribing medicinal products referred to in paragraph 3:
(a) complete the first sheet and 2 copies; the first sheet and the first copy are intended for the delivery of the prescribed medicinal product at the pharmacy; the second copy is left in the block of recipes used,
(b) indicate the information referred to in paragraph 2 and in Paragraph 18 (1).
(5) If the dispensation of the medicinal product is to be repeated, it shall be treated mutatis mutandis in accordance with Article 6 (4), in cases of delay in the provision of veterinary care, it shall be treated mutatis mutandis in accordance with Article 12 and, in the case of the issue of a prescription extract, it shall be treated mutatis mutandis in accordance with Article 15.
Data on the recipe
(1) The recipe shall include the following information:
(a) the name and, where applicable, the name, surname, address of the place of permanent residence, or place of residence in the territory of the Czech Republic, if any, if it is a stranger, and the telephone number of the keeper of the animal, if he is a natural person; for a legal person, the name or business name, registered office and telephone number; telephone numbers shall only be provided if their users agree to this;
(b) the type of animal for which the medicinal product is prescribed,
(c) the prescribed medicinal product:
1. the protected name under which the medicinal product has been authorised (10), the pharmaceutical form, the strength and the package size, or
2. the pharmaceutical name or its synonym or abbreviation given in the Czech Pharmacopoeia (11), including for its individual components in the case of the preparation of the medicinal product,
(d) instructions for use;
(e) the date of issue;
(f) an imprint of the stamp containing the name or, where appropriate, the name, surname and place of business, or place of practice of the prescribing veterinarian; where the veterinarian carries out professional veterinary activities (5) as an employee of a natural or legal person authorised to carry out professional veterinary activities (5), the name and, where appropriate, the name, surname and place of regular veterinary care of that person, if any, or the name and address, if applicable, of the legal person, telephone number; and
(g) the signature of the veterinarian.
(2) The period of validity of the recipe is governed by Article 14 mutatis mutandis.
Information on the prescription for medicated feed
(1) The prescription for medicated feeding15) contains:
(a) the name and, where applicable, the name, surname and place of business, or place of practice of the prescribing veterinarian;
(b) the name of the medicated premix16) to be used for the manufacture of medicated feed, including the indication of strength;
(c) the concentration of the active substance contained in medicated feed;
(d) the name and, where applicable, the name, surname and place of business of the breeder of the animal to which the medicated feed is to be used, if any, or the name and address of the natural person, if applicable,
(e) the name and, where appropriate, the name, surname and place of business of the person receiving the medicated feed, if any, if it is a natural person, name and registered seat, if it is a legal person (17);
(f) the address and registration number of the farm (5) where the medicated feed is to be used;
(g) the species, category and number of animals for which medicated feed is to be produced,
(h) therapeutic or preventive indication;
(i) the quantity of medicated feed;
(j) the method and time of feeding of medicated feed, including the frequency of administration and the quantity in which medicated feed is included in the daily ration, unless medicated feed is fed as a single feed;
(k) the name and, where appropriate, the name, surname and place of business of the manufacturer of medicated feed, if it is a natural person, or the name and registered office, if it is a legal person;
(l) guidelines for animal breeders, including special warnings;
(m) the date of issue of the prescription for medicated feed;
(n) the entry "The manufacture or putting into circulation of medicated feed shall not be repeated for medicated feed ',
(o) an imprint of the stamp containing the name or, where appropriate, the name, surname and place of business, or place of practice of the prescribing veterinarian; where the veterinarian carries out professional veterinary activities (5) as an employee of a natural or legal person authorised to carry out professional veterinary activities (5), the name and, where appropriate, the name, surname and place of regular veterinary care of that person, if any, or the name and address of the natural person; and
(p) the signature of the veterinarian who issued the prescription for medicated feed.
(2) The prescription for medicated feed shall be drawn up in accordance with the model of the prescription for medicated feed, which shall be published by the Institute for State Control of Veterinary Bioprafts and Medicines in its information medium.
(3) The prescription for the manufacture of medicated feed shall be drawn up by the veterinarian in five copies. One copy shall be kept by the veterinarian who has issued the prescription for medicated feed, the other 4 copies shall be transmitted by the veterinarian to the manufacturer of medicated feed.
(4) The manufacturer of the medicated feed shall keep one copy of the prescription for medicated feed, transmit one copy, using any means of data transmission, to the Regional Veterinary Administration, which is the locally competent holding where the medicated feed is to be used, and forward two copies to the distributor of the medicated feed. Where the manufacturer provides for the distribution of medicated feed produced by him himself, he shall also keep a copy for the distributor.
(5) The distributor of medicated feed, or the manufacturer who also provides for the distribution of medicated feed, shall keep one copy of the prescription for medicated feed and forward the second copy to the person referred to in paragraph 1 (e). If the recipient of the medicated feed is the veterinarian who has issued the prescription for medicated feed, he shall transmit it to the breeder when using the medicated feed.
(6) The veterinarian may request the manufacturer to provide copies of the prescription for medicated feed for the purpose of their transmission in accordance with paragraphs 3 to 5; this shall be indicated by the veterinarian on the prescription for medicated feed. In this case, the veterinarian shall draw up only 2 copies of the prescription for medicated feed. The manufacturer shall ensure that the particulars on the copies can be read and unchanged when making copies of the prescribed medicated feed.
(7) Where the producer of medicated feed is a person established in a Member State other than the Czech Republic and where the distribution of medicated feed produced by it is provided by a distributor, the responsibility of the manufacturer for the treatment of medicated feed rules referred to in paragraph 6 may be provided by the distributor of medicated feed.
Maintenance of medicated feed
(1) The veterinarian who has issued the prescription for medicated feed and the breeder who has used the medicated feed shall keep the appropriate copies of the prescription for medicated feed for at least 5 years from the date of its issue.
(2) The manufacturer of medicated feed and the distributor of medicated feed shall keep the appropriate copies of the medicated feed regulation in accordance with the requirements laid down by other legislation18).
Data on the veterinary autogenic vaccine prescription
(1) The veterinary autogenic vaccine prescription contains:
(a) the name and, where applicable, the name, surname and place of business, or place of practice of the prescribing veterinarian;
(b) indication or indication of the reason for use;
(c) the identification of the antigens or pathogens from which the autogenic vaccine is to be produced;
(d) the address and registration number of the holding from which the antigens or pathogens for the production of the veterinary autogenic vaccine are to be collected; where antigens or pathogens have already been collected under Section 71 (5) of the Drug Act, the name of the holding and the location from which the antigens or pathogens have been collected and the date of such collection shall be indicated;
(e) the species and category of animal for which the veterinary autogenic vaccine is intended,
(f) the number of doses of the veterinary autogenic vaccine or its quantity to be produced;
(g) a special warning to be given on the packaging or package leaflet of the veterinary autogenic vaccine;
(h) a stamp showing the name, surname and place of business, or place of practice of the prescribing veterinarian; where the veterinarian carries out professional veterinary activity (5) as an employee of a natural or legal person authorised to carry out professional veterinary activity (5), the name and, where appropriate, the name, surname and place of regular veterinary care of that person, if any, or its name and address, if applicable, if applicable, of the legal person; and
(i) the signature of the veterinarian who issued the prescription for the veterinary autogenic vaccine.
(2) The rules for the veterinary autogenic vaccine shall be drawn up by the competent treating veterinarian in three copies, one of which he shall retain and 2 copies shall be transmitted to the manufacturer of the veterinary autogenic vaccine. This manufacturer shall retain one copy and transmit one copy, using any means of data transmission, to the Regional Veterinary Administration within whose jurisdiction the veterinary autogenic vaccine will be used.
(3) A veterinarian may request a manufacturer of a veterinary autogenic vaccine to provide copies of a prescription for a veterinary autogenic vaccine for the purpose of their transmission in accordance with paragraph 2; this is indicated by the veterinarian on the prescription for a veterinary autogenic vaccine. In this case, the veterinarian shall draw up only 2 copies of the prescription for the veterinary autogenic vaccine. The manufacturer shall ensure that the particulars on the copies are legible and unchanged when making copies of the submitted prescription for the veterinary autogenic vaccine.
Conservation of veterinary autogenic vaccines
(1) The veterinarian who has issued the veterinary autogenic vaccine shall keep it for at least 5 years from the date of its issue.
(2) The manufacturer of a veterinary autogenic vaccine keeps a prescription for a veterinary autogenic vaccine in accordance with the requirements laid down by other legislation19).
Prescription of medicinal products for distribution to breeders
(1) The recipe on the basis of which medicinal products are to be distributed to breeders under Section 77 (1) (c) (8) of the Medicines Act (hereinafter referred to as the "prescription for distribution to breeders") cannot be used for repeated delivery.
(2) The formula for distribution to the breeder is issued by the treating veterinarian.
(3) Only a veterinary medicinal product may be prescribed for the prescription for distribution to the breeder, which
(a) is not a product containing antibiotics or chemotherapeutic agents intended for injection in accordance with the marketing authorisation decision,
(b) is not restricted for its use only by a veterinarian pursuant to Article 40 (5) of the Drug Act;
(c) it is not restricted to putting into circulation or its use under another legislation, 20)
(d) is not an immunological veterinary medicinal product which contains live agents of diseases or diseases communicable from animals to man5) or a preparation for preventive vaccination of animals against diseases and diseases communicable from animals to humans listed in the list of diseases and diseases communicable from animals to humans against which animals must not be vaccinated, 5)
(e) does not contain a substance or precursor under any other legislation, 21)
(f) the marketing authorisation shall indicate the type of animal for which it is prescribed.
(4) A prescription for distribution to the breeder may be prescribed for a veterinary medicinal product, the dispensation of which is subject to a prescription, up to a maximum of that corresponding to the need for a therapeutic bark established by the treating veterinarian for a period not exceeding 28 days. For emergency treatment, a veterinary medicinal product may be prescribed not exceeding the average weekly requirement on the holding concerned.
(5) In addition to the particulars referred to in § 17 (2) and § 18 (1), it contains a recipe for distribution to breeders.
(a) the address and registration number of the holding (5) for which the veterinary medicinal product is intended,
(b) a medical diagnosis or reason for prescribing the veterinary medicinal product;
(c) the number and category of animals for which the veterinary medicinal product is intended.
(6) When prescribing prescription medicinal products for distribution to the breeder, the treating veterinarian shall complete the first sheet and two copies. The first sheet and the first copy shall be transmitted by the prescribing veterinarian to the breeder. The second copy is retained by the veterinarian. The breeder shall keep the first sheet and hand the licence to the distributor when the veterinary medicinal products are delivered. The breeder, the veterinarian and the distributor shall keep the recipe or its signature in accordance with the requirements laid down in Section 9 (11) of the Medicines Act.
(7) Paragraph 14 (1) shall apply mutatis mutandis for the purpose of determining the duration of the distribution recipe to the breeder.
TRANSITIONAL, REPEAL AND FINAL PROVISIONS
Transitional provisions
The existing medical regulations may be used if the prescribing physician is accompanied by the relevant information provided for in this decree, until existing stocks are used up.
Repeal
The following shall be deleted:
1. Decree of the Ministry of Health No 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for medical prescriptions and the rules for their use,
2. Decree of the Ministry of Health No. 157 / 2001 Coll., amending Decree of the Ministry of Health No. 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for medical regulations and the rules for their use,
3rd Decree No. 30 / 2003 Coll., amending Decree No. 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for and the rules for their use, as amended by Decree No. 157 / 2001 Coll.,
4. Decree No. 34 / 2004 Coll., amending Decree No. 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for and the rules for their use, as amended,
5th Decree No. 643 / 2004 Coll., amending Decree No. 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for and the rules for their use, as amended,
6th Decree No. 301 / 2006 Coll., amending Decree No. 343 / 1997 Coll., laying down the procedure for prescribing medicinal products, the formalities for and the rules for their use, as amended.
Final provision
This decree shall take effect on the day of its publication.
Minister:
Dr. Julinek, MBA v. r.
Příloha č. 1
Annex No. 1 to Decree No. 54 / 2008 Coll.
MODEL RECEPT
for medicinal products containing narcotic substances included in list I2) and psychotropic substances included in list II3) and its first and second signatures
Příloha č. 2
Annex No 2 to Decree No 54 / 2008 Coll.
1) Article 1 (19) of Directive 2001 / 83 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended by Directives 2002 / 98 / EC, 2003 / 63 / EC, 2004 / 24 / EC and 2004 / 27 / EC of the European Parliament and of the Council and Regulation (EC) No 1901 / 2006. Article 1, point 21, Directive 2001 / 82 / EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products, as amended by Directive 2004 / 28 / EC.
2) Annex No. 1 to Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended.
3) Annex 5 to Act No. 167 / 1998 Coll., as amended.
5) Act No. 166 / 1999 Coll., on veterinary care and amending certain related laws (Veterinary Act), as amended.
6) Paragraph 81 of Act No. 378 / 2007 Coll., on Medicines and on Changes to Certain Related Acts (Law on Medicines).
7) Act No. 227 / 2000 Coll., on electronic signature and amending certain other laws (Act on electronic signature), as amended.
8) Article 13 of Act No. 167 / 1998 Coll., as amended.
9) Act No. 48 / 1997 Coll., on Public Health Insurance and on the amendment and addition of certain related laws, as amended.
10) § 32 of Act No. 378 / 2007 Coll.
11) § 11 (d) of Act No. 378 / 2007 Coll.
12) § 3 (1) of Act No. 378 / 2007 Coll.
13) § 2 (a) of Act No. 167 / 1998 Coll., as amended.
14) Act No. 95 / 2004 Coll., on the conditions for obtaining and recognising professional competence and specialised competence for the exercise of the medical profession of physician, dentist and pharmacist, as amended by Act No. 125 / 2005 Coll.
15) Article 2 (6) of Act No. 378 / 2007 Coll.
16) Article 2 (5) of Act No. 378 / 2007 Coll.
17) § 74 paragraph 7 of Act No. 378 / 2007 Coll.
18) For example, Sections 73 and 74 of Act No. 378 / 2007 Coll.
19) For example, Sections 71 and 72 of Act No. 378 / 2007 Coll.
20) Decree No 291 / 2003 Coll., on the prohibition of the administration of certain substances to animals whose products are intended for human consumption and on the monitoring (monitoring) of the presence of unauthorised substances, residues and contaminants for which animal products could be harmful to human health, in animals and in their products, as amended.
21) Act No. 167 / 1998 Coll., as amended.
22) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council on drug precursors.
23) Commission Implementing Directive 2012 / 52 / EU of 20 December 2012 laying down measures to facilitate the recognition of medical prescription issued in another Member State.
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Regulation Information
| Citation | Decree No. 54 / 2008 Coll., on the method of prescribing medicinal products, the particulars on the prescription and the rules of use of the prescription |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 25.02.2008 |
|---|---|
| Effective from | 25.02.2008 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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