Decree of the Ministry of Health No. 304 / 1998 Coll.
Ordinance of the Ministry of Health laying down cases where no export permit is required for the export of excipients, details of the registration of addictive substances, preparations and precursors and the documentation of addicts
Valid
Order
Effective from 01.01.1999
304
DECLARATION
Ministry of Health
of 3 December 1998
laying down cases where no export authorisation is required for the export of excipients, details of the registration of addicts, preparations and precursors and of the substance documentation
The Ministry of Health provides, pursuant to § 20 (3), § 32 (2) and § 33 (2) of Act No. 167 / 1998 Coll., on addictive substances and on the amendment of certain other laws, hereinafter referred to as "the Act":
INTRODUCTORY PROVISIONS AND DETERMINATION OF THE LIMITS OF EXCIPIENTS ON THE MARKET AND EXPORT
Preliminary provisions
This decree sets out, in accordance with the law of the European Communities (1), cases where no export authorisation is required for the export of excipients, details of the registration of addicts, preparations and precursors and the documentation of addicts.
Limited quantities of excipients when placed on the market and exported
(1) A declaration by the customer (Paragraph 12 (2) of the Act) when placing on the market the excipients listed in Annex 10 to the Act, with the exception of potassium permanganate, is not required where the total quantity of such substances placed on the market per calendar year does not exceed that set out in Annex 8 to this Decree.
(2) When placing on the market of the excipients listed in Annex 10 to the Act, documentation, including customer declarations and records, shall not be required in cases where the total quantity of such substances placed on the market in a calendar year does not exceed the quantity listed in Annex 8 to this Decree (Section 32 (6) of the Act).
(3) In the case of exports of potassium permanganate and acetic acid anhydride (Section 20b (2) of the Act), no notification of the anticipated export shall be required if their quantity does not exceed the quantity set out in Annex 9 to this Decree.
EVIDENCE OF PRECIOUS AND EXCIPIENTS
Common provisions on keeping records
(1) The records of the treatment, import and export of addictive substances and preparations, and of the treatment of precursors and consumables (hereinafter referred to as "the register"), shall be kept entirely, in a conclusive manner (in writing or by computer), in such a way as to show truthfully the facts covered by it. The processing of personal data in the register shall be governed by a special law. (1b)
(2) The addicts, precursors and excipients (1c) are identified by the name given in the relevant Annex to the Act; 1 (d) are referred to only by registered name.2)
(3) Records shall be kept in fixed books with numbered sheets (hereinafter referred to as "the register"), unless otherwise specified. The records shall be entered in the records on the date on which the recorded event occurred.
(4) The compliance of the records with the actual situation shall be verified by inventory. The inventory shall be carried out monthly according to the condition on the last day of the calendar month even if there has been no record of movement during the calendar month. The execution of the inventory shall be recorded in the register indicating the date of the inventory, the names, surnames, functions and signatures of the persons who carried out the inventory. The inventory record shall indicate the initial state of the reference period, total income and output and the state at the inventory date of all the items monitored. If the difference between the actual and the registered situation is found in the inventory, an inventory report shall be drawn up indicating the differences identified, including their justification, the date, name and surname, function and signature of the persons who carried out the inventory, including the responsible person, if any. If the responsible person has not been appointed, the record of the check shall be signed by the entrepreneur himself, if it meets the requirements imposed on the responsible person within the meaning of Article 8 (6) of the Act.
(5) Corrections to the records shall be carried out in such a way that the contents of the original alert can be ascertained and the corrected alert shall be dated and dated, by name, surname, function and signature of the person who corrected the alert.
Registration books
(1) The register shall contain:
(a) the name and surname or business name (hereinafter referred to as "the name") and the place of business, or the address of the place of permanent residence or residence in a Member State of the European Union (hereinafter referred to as "residence") of the undertaking or business company or the name and registered office of the legal person carrying out the activity in respect of which the registration is kept, or, where appropriate, the designation of the organisational component or activity to which the registration relates;
(b) the name and surname of the natural persons who enter the records in the registers, their residence and their signature and the date on which they carry out the records;
(c) the date of transmission of the register for use and termination of use;
(d) the number of sheets with the number of the first and the last sheets,
(e) a list of registered addicts, preparations and precursors, indicating the number of sheets reserved for the registration of individual addicts, preparations and precursors, with the exception of the register for pharmacies.
(2) Registration books may be kept separately for each organisational component.
Accounting by computer
(1) Prepared mass-produced medicinal products containing addictive substances listed in Annexes 2, 6 or 7 to the Act, or medicinal products containing narcotic substances listed in Annex 1 to the Act, and listed in Annex 8 to the Act, or medicinal products containing ephedrine or medicinal products containing more than 30 mg of pseudoephedrine in the unit of the pharmaceutical form, may be recorded by means of computer techniques, provided that it is obtained at least
(a) once a day security copies of the data file;
(b) twice a year, archival copies of the data file to a non-descriptable storage medium with a manufacturer guaranteed the lifetime of writing for at least 5 years.
(2) The accounting by computer equipment must be conducted in such a way as to allow separate daily monitoring of movement and stock levels of individual manufactured mass-produced medicinal products containing addictive substances listed in Annexes 2, 6 and 7 to the Act, of medicinal products containing narcotic substances listed in Annex 1 to the Act and of those listed in Annex 8 to the Act and of medicinal products containing ephedrine or pseudoephedrine, allowing them to be traced for 5 years.
(3) The computerised records shall include:
(a) the name of the preparation,
(b) the date of receipt or issue;
(c) the number of the proof of receipt and delivery;
(d) the name and address of the undertaking of the natural person or business company or the name and registered office of the legal person or designation and the registered office of its organisational body from which the products have been accepted, or the name and address of the undertaking of the natural person or of the commercial firm, or the name and registered office of the legal person or designation and the registered office of its organisational body which have been issued the products;
(e) the quantities and lots of products accepted or issued,
(f) stocks as at the last day of the reference period. For the purposes of this decree, the reference period shall mean, in particular, periods of time intended to carry out inventories, mandatory reporting (Section 26 of the Act) and control activities (Section 34 of the Act).
(4) If the register is kept in accordance with paragraphs 1 and 2, it may not be kept in accordance with Section 3.
(5) An inventory shall be carried out according to the state at the last day of the calendar quarter when keeping computer records. The inventory shall be carried out in accordance with Article 2 (4), including an indication of the initial state of the reference period, the total revenue and expenditure and the stock at the inventory date of all the items monitored.
(6) Excipients may be recorded using computer techniques mutatis mutandis in accordance with paragraphs 1 and 2. The records shall include:
(a) for the excipients listed in Annex 10 to the Act, with the exception of the manufacture and placing on the market of potassium permanganate: the name of the auxiliary substance, the date of receipt or delivery, the number of the document of receipt and delivery, the name and address of the undertaking of the natural person or business company, or the name and address of the undertaking of the entity which issued it, the quantity received, issued or produced and the state of stocks,
(b) for the excipients listed in Annex 11 to the Act, similar data as for the excipients listed in Annex 10 to the Act, except for stocks and quantities produced.
(7) The keeping of records referred to in paragraph 6 shall not be subject to the inventory obligation referred to in paragraph 5.
Registration in pharmacies
(1) The pharmacy shall carry out treatment of addictive substances, preparations and precursors which are not required to be authorised for treatment (Sections 5 and 6 of the Act), records of addictive substances included in Annex 1 or 5 to the Act, including preparations containing them in the manner laid down in paragraph 2, with the exception of medicinal products containing narcotic substances listed in Annex 1 to the Act and listed in Annex 8 to the Act.
(2) The model of the register sheet for keeping records referred to in paragraph 1 is set out in Annex 2 to this Decree.
(3) The pharmacy shall also keep records of addictive substances listed in Annexes 2, 6 and 7 to the Act and of preparations containing, precursors listed in Annex 9 to the Act, preparations containing ephedrine and preparations containing pseudoephedrine in quantities greater than 30 mg per unit of pharmaceutical form, using the data contained in the register under a specific legislation. (2a) This record may be kept by computer. The record shall contain the following information:
(a) the name, for the preparation including its strengths (2b) and package size,
(b) the date of receipt and the date of issue;
(c) the number of the receipt document;
(d) the quantity received and the quantity issued,
(e) current stocks.
(4) Where the records referred to in paragraph 3 are kept, there is no obligation to carry out the inventory pursuant to Article 2 (4).
(5) The registration referred to in paragraph 3 shall not be subject to the provisions of Section 4. Where a pharmacy keeps records using computer techniques, it shall keep data media containing the records referred to in Section 11.
(6) The registration of the treatment of addictive substances, preparations and precursors for which authorisation is required (Section 4 of the Act) is governed by Section 7 of this Decree.
Record keeping in other healthcare institutions, social care establishments and veterinary care
(1) In other health establishments, in social care establishments and in the provision of veterinary care, the treatment of addictive substances, preparations and precursors to which no authorisation for treatment is required (Section 4 of the Act), the registration of mass-produced medicinal products containing addictive substances listed in Annex 1 or Annex 5 to the Act.
(2) The adaptation of the register sheet to keep records referred to in paragraph 1 is laid down in Annex 3 to this Decree.
(3) The registration of the treatment of addictive substances, preparations and precursors for which authorisation for treatment is required (Section 4 of the Act) is governed by Section 7 of this Decree.
The keeping of a register of addictive substances listed in Annexes 3 and 4 to the Act and preparations shall contain:
(1) Legal persons and natural persons - entrepreneurs are responsible for the treatment of the addictive substances listed in Annexes 3 and 4 to the Act and for the preparation of such substances.
(2) The adaptation of the register sheet to keep records referred to in paragraph 1 is laid down in Annex 6 to this Decree.
Reporting on the treatment of addictive substances, preparations or precursors without authorisation of treatment
(1) When dealing with addictive substances, products containing addictive substances listed in Annex 1 or Annex 5 to the Act or precursors of persons listed in Section 5 (7) or Section 6 (3) of the Act, registration records shall be kept.
(2) The model of the register sheet is set out in Annex 5 to this Decree.
Registration in the manufacture, processing, packaging and storage of addictive substances, preparations or precursors on the basis of authorisation to deal with them
(1) In the manufacture, processing or packaging of addictive substances, preparations or precursors on the basis of authorisation to treat them, records of addictive substances, preparations or precursors shall be kept.
(a) manufactured;
(b) accepted;
(c) stored;
(d) removed from storage;
(e) overworked;
(f) consumed in the manufacture of other addictive substances, preparations or substances which are not addictive substances;
(g) declared as losses or waste as foreseen by the production technology regulation;
(h) transmitted for disposal or disposal;
(i) missing or residing, stating the reason.
(2) The model of the register of manufacture of products containing addictive substances is set out in Annex 4 to this Decree.
(3) The model of the list of records of the storage of addicts, preparations and precursors for persons who produce, process or package addictive substances, preparations or precursors on the basis of a treatment authorisation, is set out in Annex 5 to this Decree.
(1) In the storage of addictive substances, products containing addictive substances listed in Annex 1 or Annex 5 to the Act or precursors on the basis of the authorisation to treat them, except in the case of the procedure provided for in Sections 5, 6, 6a or 7, records of the storage of addictive substances, preparations or precursors shall be kept.
(2) The model of the register for the storage of addicts, preparations and precursors is set out in Annex 5 to this Decree.
DOCUMENTATION
(1) The documentation on the treatment of addictive substances, preparations, precursors and excipients consists of:
(a) registers;
(b) data media containing computer-based data records;
(c) inventory protocols;
(d) the entries for the disposal of addictive substances, preparations, precursors (Section 14 of the Act) and of the excipients listed in Annex 10 to the Act;
(e) protocols for the loss or destruction of an addictive substance, preparation, precursor or excipients listed in Annex 10 to the Act;
(f) minutes of checks carried out (Section 34 of the Act);
(g) all official decisions, including foreign decisions, concerning the treatment and export and import of addictive substances, preparations and precursors, as well as the export and import of macaquin;
(h) any official decisions (Paragraph 16 (6) of the Act) concerning the registration of producers, exporters, importers and sellers of excipients and all decisions, including decisions taken by the competent authorities of the countries of the European Communities or third countries concerning their export or import;
(i) copies of reports (Sections 26 to 30 and 43 of the Act);
(j) commercial documents such as invoices, bills of lading, transport and other delivery documents, lists of goods, administrative documents, delivery notes, customs documents containing sufficient information for reliable identification: the name of addicts or precursors, as specified in the annexes to the Act, the quantity and weight of addicts, the name and quantity of products containing addictive substances, the name and quantity of preparations containing ephedrine or preparations containing pseudoephedrine in quantities greater than 30 mg in the unit of pharmaceutical form, the quantity and weight of precursors, in the case of a mixture of quantities and weight of products, as well as well as well as the quantity and weight of preparations and percentages of precursors which are included in the product as referred to in Section 1 (2) (b) of the Act], the name and residence of the undertaking of the natural person or of the company or of the name and of the legal persons involved in the substance, products and of the product,
(k) documents relating to the acquisition, sale or disposal of the tablet, the auctioning boiler and the granulation boiler;
(l) the customer's declaration in accordance with the specific legislation 2d) for precursors and auxiliary substances listed in Annex 10 to the Act;
(m) the registration issued (Article 16 (1) of the Act), commercial documents such as invoices, bills of lading, transport and other delivery documents, lists of goods, administrative documents, delivery notes, customs documents containing sufficient information for a reliable identification: the name of the excipients, as specified in the annexes to the Act, the quantity and weight of the excipients, in the case of a mixture of the quantity and weight of the product, as well as the quantity and weight or percentage of the excipients contained in the product, the names and addresses of the persons involved, or the names and addresses of the legal entities, including the final consignee. (c)
(2) In addition to the documentation referred to in paragraph 1, the first copies of the medical prescription or, where appropriate, the first sheets of the medical prescription with a blue stripe and the first certificate of the blue stripe demand (§ 13 (2) of the Act) shall be kept at the pharmacy.
(3) In other health or institutional welfare establishments, all second copies of the recipes used (3), marked with a blue stripe and first sheets and all second and third copies of the applied requisites (4), marked with a blue stripe, shall be kept in addition to the documentation referred to in paragraph 1.
Protocols and minutes
When taking the protocols and entries referred to in Articles 9 (1) (c), (d) and (e), the common provisions for keeping records shall be followed (Article 2). Minutes pursuant to § 9 (1) (c), (d), (e) or (k) must always be signed by the responsible person (§ 9 of the Act). If the person responsible has not been appointed, the registration shall be signed by the entrepreneur himself if he meets the requirements imposed on the person responsible within the meaning of Article 8 (6) of the Act. In the case of excipients, the entries and protocols referred to in Article 9 (1) (d) and (e) shall be signed by a person authorised to act as a legal person or a natural person or person authorised by them in writing.
Preservation of documentation
(1) The documentation shall be stored in such a way as to prevent its loss, destruction or theft and the possibility of its misuse.
(2) Documentation relating to treatment
(a) addictive substances and preparations containing them shall be kept for a period of 5 years (Paragraph 33 (1) of the Act) from the date of the receipt of the document or, where appropriate, from the last entry therein, whichever is the later;
(b) precursors and auxiliary substances shall be kept for at least 3 years (Paragraph 33 (1) of the Act) from the end of the calendar year in which the treatment took place.
Efficacy
This Decree shall take effect on 1 January 1999.
Minister:
Dr. David, CSc.
Příloha č. 2
Annex No 2 to Decree No. 304 / 1998 Coll.
Model of the register sheet for pharmacies
Příloha č. 3
Annex No. 3 to Decree No. 304 / 1998 Coll.
Model sheet of records of other health establishments, social care facilities and veterinary care
Příloha č. 4
Annex No. 4 to Decree No. 304 / 1998 Coll.
Model sheet sheet of product manufacture containing addictive substances (NL)
Příloha č. 5
Annex No. 5 to Decree No. 304 / 1998 Coll.
Model for the record book of storage
Příloha č. 6
Annex 6 to Decree No. 304 / 1998 Coll.
Model for the record book of storage
Příloha č. 8
Annex No 8 to Decree No 304 / 1998 Coll.
Annual limit quantity for persons intending to place on the market the auxiliary substances listed in Annex 10 to the Act (Sections 12 (3) and 32 (6))
| Mezinárodní nechráněný název (INN) v českém jazyce | Množství |
|---|---|
| Anhydrid kyseliny octové | 20 litrů |
| Kyselina antranilová | 1 kg |
| Kyselina fenyloctová | 1 kg |
| Piperidin | 0,5 kg |
Including salts of scheduled substances in all cases where the existence of such salts is possible.
It also applies to mixtures of these substances when converted into the content of the pure substance contained in the mixture.
Příloha č. 9
Annex No. 9 to Decree No. 304 / 1998 Coll.
Limit quantities for persons intending to export acetic acid anhydride or potassium permanganate related to the notification of anticipated exports (Section 20b (2) of the Act)
| Mezinárodní nechráněný název (INN) v českém jazyce | Limitní množství v kg (včetně) |
|---|---|
| Anhydrid kyseliny octové | 100 |
| Manganistan draselný | 100 |
1) Council Directive 92 / 109 / EEC of 14 December 1992 on the manufacture and placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances. Commission Directive 93 / 46 / EEC of 22 June 1993 replacing and amending the Annexes to Council Directive 92 / 109 / EEC on the manufacture and placing on the market of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances. Council Regulation (EEC) No 3677 / 90 of 13 December 1990 on measures to be taken to prevent the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances, as amended by Council Regulation (EEC) No 900 / 92 and Council Regulation (EC) No 988 / 2002. Commission Regulation (EC) No 1485 / 96 of 26 July 1996 laying down detailed rules for the application of Council Directive 92 / 109 / EEC as regards customer declarations concerning the specific use of certain substances used in the illicit manufacture of narcotic drugs and psychotropic substances, as amended by Commission Regulation (EC) No 1533 / 2000.
(1a) Article 2 (3) of Council Regulation (EEC) No 3677 / 90.
1b) Act No. 101 / 2000 Coll., on the protection of personal data and on the amendment of certain laws, as amended.
(1c) Article 2 (2) of Council Regulation (EEC) No 3677 / 90.
1d) § 2 paragraphs 3 and 11 of Act No. 79 / 1997 Coll., on Medicines, and on amendments and additions to certain related laws.
2) Articles 9 (1) (a) (1) and 23 of Act No. 79 / 1997 Coll.
2a) § 21 (1) (e) and (g) of Act No. 79 / 1997 Coll., as amended by Act No. 149 / 2000 Coll.
2b) Paragraph 3 (5) (c) (2) of Decree No 343 / 1997 Coll., laying down the procedure for the prescription of medicinal products, the formalities for prescription and the rules for their use.
(2c) Article 2 (1) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92 and Council Regulation (EC) No 988 / 2002.
(2d) Commission Regulation (EC) No 1485 / 96, as amended by Commission Directive 93 / 46 / EEC and Commission Regulation (EC) No 1533 / 2000.
3) Paragraph 3 (5) (b) of Decree No 343 / 1997 Coll., laying down the procedure for the prescription of medicinal products, the formalities for the prescription and the rules for their use.
4) Paragraph 3 (6) of Decree No 343 / 1997 Coll.
5) Article 2 (4) of Council Regulation (EEC) No 3677 / 90, as amended by Council Regulation (EEC) No 900 / 92.
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Regulation Information
| Citation | Decree of the Ministry of Health No. 304 / 1998 Coll., laying down cases where no export permit is required for the export of excipients, details of the registration of addicts, preparations and precursors and the documentation of addicts |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 31.12.1998 |
|---|---|
| Effective from | 01.01.1999 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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