Decree No. 34 / 2004 Coll.
Decree amending Decree No 343 / 1997 Coll., laying down the procedure for the prescription of medicinal products, the formalities for medical prescriptions and the rules for their use, as amended
Valid
Effective from 01.02.2004
34
DECLARATION
of 23 January 2004
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
The Ministry of Health, in agreement with the Ministry of Agriculture, the Ministry of Defence, the Ministry of Interior and the Ministry of Justice, provides, pursuant to Article 75 (3) of Act No. 79 / 1997 Coll., on Medicines and on amendments and additions to certain related laws:
1. the heading of Section 1 reads as follows: "Introductory provision."
2. In Article 1, the following paragraph 1 is inserted:
"(1) This Decree of the Ministry of Health sets out, in accordance with the law of the European Communities, the procedure for prescribing medicinal products, the formalities for the prescription and the rules for their use.
1) Council Directive 90 / 167 / EEC laying down the conditions for the preparation, placing on the market and use of medicated feedingstuffs in the Community. Directive 2001 / 82 / EC of the European Parliament and of the Council on the Community code relating to veterinary medicinal products. '
The current text is referred to as paragraph 2 and footnote 1 is renumbered as footnote 1a), including the references to footnote 1.
3. In Article 1 (2) (a), at the end of the text in point 2, the words "the model of the recipe form is set out in Annex 3 to this Decree 'are added.
4. In Article 1 (2) (b), the words "medicinal products, including transfusion products', are inserted after the words" orders'.
5. In Paragraph 2 (2), the words "competent insurance undertaking 'are replaced by the words" competent health insurance undertakings and regional authorities' according to the place of operation of the health establishment '.
6. In Article 2a (8), the words "including their signatures' shall be inserted after the words" marked with a blue stripe '.
7. In Article 2a (9), the words "including their signatures' shall be inserted after the words" marked with a blue stripe 'and the words "impaired forms'.
8. After Paragraph 2a (10), the words "including their signatures' shall be inserted after the words" marked with a blue stripe '.
9. in Article 3 (1) (a), the words "or flunitrazepam" shall be deleted;
10.Paragraph 3 (2) reads as follows:
"(2) No more than five types of medicinal products containing I2) or Class II.3 psychotropic substances may be prescribed per application."
11. in Article 3 (3), the word "more" shall be deleted;
12. in § 4 (1) (c) (2):
"2. an individually prepared medicinal product using pharmaceutical names or their synonyms or abbreviations listed in the pharmacopoeia,"
13. in Article 4 (1) (d) (1), the words "designated decrement7)" shall be replaced by the words "designated pharmacopis7";
footnote 7 is replaced by the following:
"7) § 7 (d) and (e) of Act No. 79 / 1997 Coll., on Medicines and on Amendments and Additions to Certain Related Acts, as amended by Act No. 149 / 2000 Coll. and Act No. 129 / 2003 Coll. '.
14. in Article 4 (1) (d) (3):
'3. "I" - if the medicinal product is fully covered by health insurance,
"C '- if the medicinal product is partly covered by health insurance,
"P" - if the medicine is fully covered by the patient, '.
15. in Article 4 (1) (d), point 5 is deleted;
16. in Article 4 (2), the words "which is not the competent expert" shall be replaced by "other expertise."
17. in Article 4 (2) (b):
"(b) contain on the back the name, surname and expertise of the physician who recommended the prescription of the medicinal product."
18. in Paragraph 4 (3):
"(3) For partial reimbursement by patients, medicinal products marked with" C "are prescribed and for full reimbursement by the patient, medicinal products marked with" P "are prescribed in accordance with Sections 3 and 4 (1) (b) to (h)."
19. In Article 4 (5), at the end of the sentence, the words "and the period of validity 'are deleted and the third sentence is replaced by the words" Repeating the expenditure must not be indicated on the prescription of medicinal products containing narcotic substances, psychotropic substances, ephedrine or pseudoephedrine in excess of 30 mg per unit of pharmaceutical form'.
20. In Article 4 (6), in the introductory part of the text, the words "" Rev. "and" "shall be deleted on the front page of the prescription.
21. In Article 4 (6) (b), the words "or the approval of a repeat prescription" shall be inserted after the words "or the approval of a repeated prescription" and the words "the granting of a prior consent" shall be inserted after the words "his prior consent."
22. in Article 4, the following paragraph 7 is added:
"(7) The recipe for medicinal products for human use prescribed by a doctor providing medical care to himself, his husband, his parents, grandparents, children, grandchildren and siblings, provided that his expertise is guaranteed by the Czech Chamber of Medicine or the Czech Chamber of Dentistry, (7a) contains the particulars referred to in paragraphs 1 (a) to (e) and (g) to (h) and must be accompanied by the words" for the needs of the family. "
7a) § 17 (13) (a) of Act No. 48 / 1997 Coll. '.
23. in Article 6 (1) (b) (2):
"2. an individually prepared medicinal product using pharmaceutical names or their synonyms or abbreviations listed in the pharmacopoeia,"
24. in Article 6 (2), the words "computer techniques" are replaced by the words "electronic means."
25. in Article 6 (2) (a), the words "(d)" shall be inserted after the words "letters."
26. In Article 6, paragraphs 4 to 6 are added:
"(4) The application for transfusions must contain the following particulars:
(a) name of provider, IČO, department, IČP,
(b) the name, surname, date of birth and, where appropriate, the natural number of the intended consignee of the transfusion preparation. Where the necessary data are not known, an indication clearly identifying the intended beneficiary shall be provided,
(c) reason for administration of the transfusion product or diagnosis,
(d) blood type [ABO and Rh (D)],
(e) transfusion history: previous transfusion, parturition, pregnancy, etc.,
(f) the type of transfusion preparation (namely listed), the number in pieces or TU, the day and hour of administration,
(g) any subsequent modification of the transfusion preparation (e.g. deleucotization, exposure, etc.),
(h) the stamp of the supplier;
(i) the date of issue of the application;
(j) the name, surname and signature of the physician requesting the transfusion.
(5) In case an immunohaematologic examination is required at the same time and a sample is provided, the following shall be indicated on the request for transfusion products in addition to the data referred to in paragraph 4:
(a) the type of test required (e.g. blood type examination, irregular antibodies, compatibility test);
(b) the date of sampling;
(c) the name of the person who took the sample;
(d) the code number of the health insurance undertaking of the recipient of the transfusion product.
The sample for laboratory examination must be unmistakable and the accuracy of the data must be verified by signing the person who took the sample.
(6) An application for transfusions applied by the computer shall contain the particulars referred to in paragraphs 4 (a) to (j) and 5 (a) to (d), as the case may be, and the authorisation referred to in points (h) and (j) shall be established in a different unambiguous manner. "
27. in Article 7 (1), the words "in the case of medicinal products for local use" shall be added at the end of point (a).
28. in Article 7 (1) (b):
"(b) other medicinal products seven calendar days, unless otherwise specified by the prescribing physician, starting on the day of issue,"
29. in Paragraph 7 (2):
"(2) The recipe for repeated delivery shall be valid for a maximum period of six months from the date of issue."
30. in Article 7 (4), "five" is replaced by "seven."
(31) In Article 8, the sentence "In the case of repeated expenditure pursuant to Article 4 (5) shall be added at the end of paragraph 1, where the recipe is a necessary document for the purposes of control."
32. in Article 8 (3), the words "except for repeated expenditure" shall be inserted after the words "the recipe."
33. In Article 9, the current text becomes paragraph 1 and the following paragraph 2 is added:
"(2) The document issued by the recipe referred to in § 1 (2) (a) (2) and (3), containing the particulars referred to in § 4 and 5, is part of the medical documentation of the patient. The receipt of the sent request pursuant to § 1 (2) (b) containing the particulars referred to in § 6 is part of the file documentation of the relevant department of the provider. '
34. in Article 13 (1) (f), including footnote 9,
"(f) a stamp bearing the name, surname (s) and place of business of the prescribing veterinarian; where the veterinarian carries out a professional veterinary activity (9) as an employee of a natural or legal person authorised to carry out a professional veterinary activity, the name, surname and permanent residence of that person, if any, or the name and address of the legal person; and
9) Act No. 166 / 1999 Coll., on Veterinary Care and the amendment of certain related laws (Veterinary Act), as amended by Act No. 29 / 2000 Coll., Act No. 154 / 2000 Coll., Act No. 102 / 2001 Coll., Act No. 120 / 2002 Coll., Act No. 76 / 2002 Coll., Act No. 309 / 2002 Coll., Act No. 320 / 2002 Coll. and Act No. 131 / 2003 Coll. '.
35. in Article 13 (3), the words "and for a distributor" shall be deleted;
36. Paragraph 14, including the title and footnotes No 10) and 11) shall read as follows:
Requirements for medicated feed and handling
(1) The prescription for medicated feeding10) contains at least the following elements:
(a) the name, surname and place of business of the prescribing veterinarian;
(b) the name of the medicated premixture to be used for the manufacture of medicated feed, including the indication of strength;
(c) concentration of active substance in medicated feed;
(d) the name, surname and place of business of the breeder of the animal to which the medicated feed is to be used, if it is for a natural person, or the name and address of the legal person;
(e) the name, surname and place of business of the person receiving the medicated feed, if any, or the name and address of the natural person (§ 41k (13) of the Act);
(f) identification of the holding, (4) 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 (preventive) indications;
(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, 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 may not be repeated for medicated feed";
(o) a stamp showing the name, surname (s) and place of business of the prescribing veterinarian; where the veterinarian carries out a professional veterinary activity as an employee of a natural or legal person authorised to carry out a professional veterinary activity, the name, surname and place of business of that person, if any, or the name and address of the legal person; and
(p) the signature of the veterinarian who issued the prescription for medicated feed.
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.
(2) 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 four copies shall be transmitted by the veterinarian to the manufacturer of medicated feed.
(3) The manufacturer of the medicated feed shall keep a copy of the prescription for medicated feed, transmit it to the Regional Veterinary Administration, which shall be the responsible holding where the medicated feed is to be used, and forward the two copies of the prescription for medicated feed to the distributor of the medicated feed, where the manufacturer himself ensures the distribution of the medicated feed he has produced, the manufacturer of the medicated feed shall also keep the prescription for medicated feed intended for the distributor.
(4) The distributor of medicated feed, or, in the case referred to in paragraph 3, the manufacturer of medicated feed, shall keep a copy of the prescription for medicated feed and forward a copy to the person referred to in the prescription for medicated feed as his consignee; where the recipient of the medicated feed is the veterinarian who has issued the prescription for medicated feed, that veterinarian shall, when using the medicated feed, transmit that copy to the breeder of the prescription for medicated feed.
(5) The veterinarian who has issued the prescription for medicated feed and the breeder shall keep the appropriate copies for at least five years from the date of issue.
(6) The manufacturer of medicated feed and the distributor of medicated feed shall keep the relevant provisions for medicated feed in accordance with the requirements laid down in a specific legislation. 11)
(7) The veterinarian shall be entitled to request the manufacturer to provide copies of the prescription for medicated feed, which the veterinarian shall transmit to the manufacturer of medicated feed in accordance with paragraph 2, for the purpose of their transmission in accordance with paragraphs 3 and 4; this shall be indicated by the veterinarian on the prescription for medicated feed. In this case, the veterinarian shall draw up only two copies of the prescription for medicated feed.
(8) The manufacturer, when making copies of the medicated feed Regulation referred to in paragraph 7, shall ensure that the particulars given on the prescription remain legible and shall exclude any changes to the particulars given in the medicated feed Regulation.
(9) For the purpose of the transmission of a prescription for medicated feed to the competent Regional Veterinary Administration, the manufacturer of medicated feed shall be entitled to use means for data transmission, such as fax connections.
(10) 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 is provided by a distributor, the manufacturer's responsibility for the treatment of medicated feed rules referred to in paragraphs 2, 3 and 7 to 9 may be provided by the distributor of medicated feed. This is without prejudice to the obligation of the veterinarian to forward one copy of the prescription for medicated feed to the manufacturer of medicated feed.
10) § 41j (2) of the Act.
11) Sections 6 and 27 of Decree No. 296 / 2000 Coll., which provides for good manufacturing practice, good distribution practice and closer conditions for the calling of manufacture and distribution of medicines, including medicated feedingstuffs, as amended by Decree No. 256 / 2003 Coll. '
37. The following Section 14a is inserted after Section 14, including the title and footnote 12:
Requirements for veterinary autogenic vaccines and their handling
(1) The prescription for the production of the veterinary autogenic vaccine shall contain at least the following particulars:
(a) the name, surname and place of business of the prescribing veterinarian;
(b) indication (indication of the disease),
(c) the identification of the antigens or pathogens from which the autogenic vaccine is to be produced;
(d) the identification of the holding and the location from which the antigens or pathogens for the production of the veterinary autogenic vaccine are to be collected;
(e) the species and category of animal for which the veterinary autogenic vaccine is intended,
(f) the quantity of veterinary autogenic vaccine to be produced (number of doses),
(g) a special warning to be given on the packaging or package leaflet of the veterinary autogenic vaccine;
(h) a stamp bearing the name, surname (s) and place of business of the prescribing veterinarian; where the veterinarian carries out a professional veterinary activity as an employee of a natural or legal person authorised to carry out a professional veterinary activity, the name, surname and place of business of that person, if it is a natural person, or its name and address, if it is a legal person; and
(i) the signature of the veterinarian who issued the prescription for the veterinary autogenic vaccine.
(2) The prescription for the production of the veterinary autogenic vaccine shall be drawn up by the competent treating veterinarian in triplicate. One copy shall be kept by the veterinarian who has prescribed the prescription for the production of the veterinary autogenic vaccine and the other two copies shall be transmitted to the manufacturer of the veterinary autogenic vaccine.
(3) The manufacturer shall keep a copy of the prescription for the production of the veterinary autogenic vaccine and transmit it to the Regional Veterinary Administration within the scope of which the veterinary autogenic vaccine will be used.
(4) The veterinarian who has issued the prescription for the production of the veterinary autogenic vaccine shall keep the original of the prescription for at least five years from the date of its issue.
(5) A manufacturer of veterinary autogenic vaccines shall keep the draft of a prescription for the production of an autogenic vaccine in accordance with the requirements laid down in a specific legislation. 12)
(6) The veterinarian shall be entitled to request the manufacturer of the veterinary autogenic vaccine to provide copies of the prescription for the production of the veterinary autogenic vaccine which the veterinarian shall transmit to the manufacturer of the veterinary autogenic vaccine in accordance with paragraph 2 for the purpose of their transmission in accordance with paragraph 3; this shall be indicated by the veterinarian on the prescription for the production of the veterinary autogenic vaccine. In this case, the veterinarian shall draw up only two copies of the prescription for the production of the veterinary autogenic vaccine.
(7) For the purpose of the transmission of a prescription for the production of a veterinary autogenic vaccine to the competent Regional Veterinary Administration, the manufacturer of a veterinary autogenic vaccine shall be entitled to use means for data transmission, such as fax connections.
12) § 6 of Decree No. 296 / 2000 Coll. '
38. Annex No 1 reads as follows:
"Annex No 1 to Decree No 343 / 1997 Coll.
39. The following Annex 3 is inserted after Annex 2:
"Annex No 3 to Decree No 343 / 1997 Coll.
Transitional provision
The existing recipe forms may be used if they are accompanied by the symbols referred to in Article 4 (1) (d) (3) until 31 December 2005.
Efficacy
This Decree shall take effect on 1 February 2004, with the exception of the provisions of point 36 as regards Paragraph 14 (10), which shall take effect on the date of entry into force of the Treaty of Accession of the Czech Republic to the European Union.
Minister:
Dr. Součková v. r.
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Regulation Information
| Citation | 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 |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 30.01.2004 |
|---|---|
| Effective from | 01.02.2004 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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