Decree No. 123 / 2006 Coll.
Ordinance on the registration and documentation of addictive substances and preparations
Valid
Effective from 01.05.2006
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123
DECLARATION
of 31 March 2006
on the registration and documentation of addictive substances and preparations
The Ministry of Health provides pursuant to Sections 32 (3) and 33 (2) of Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 117 / 2000 Coll., Act No. 362 / 2004 Coll. and Act No. 74 / 2006 Coll., hereinafter "the Act ':
EVIDENCE OF MEDICINAL PRODUCTS AND PRODUCTS
COMMON PROVISIONS ON THE EVIDENCE OF PRESIDENTS AND PRODUCTS AND INVENTORS
Registration requirements
(1) The records of the treatment, import and export of addictive substances and preparations containing them (hereinafter referred to as "the register") shall be kept in writing in bound books with numbered sheets (hereinafter referred to as the register). The records may be kept electronically (hereinafter referred to as "electronic records") in the cases provided for in this Decree.
(2) The record shall always be kept in full and in accordance with this Decree in such a way as to show truthfully the facts which are its object. The compliance of the records with the actual status of the records or electronic records shall be verified by inventory.
(3) The addictive substances are identified as referred to in the Government Regulation on the lists of addictive substances (12), medicinal products (1) and their registered names (2).
Registration books
(1) The ledger, in addition to its own records under Title II, shall always contain:
(a) the name and, where appropriate, the names and surnames, the business name or the name and address of the registered office of the person holding the register, including the name and address of the establishment where the substance and preparations which are subject to registration under the law and this decree are actually carried out, provided that the address of that establishment is different from that of the registered office;
(b) the name and, where applicable, the names of the natural persons entering the records, their address of permanent residence and, if they do not have a permanent residence, the address of residence and the signature (hereinafter referred to as "signature") and the date on which those persons make the records,
(c) the date of transmission of the register for use and termination of use;
(d) the total number of sheets, indicating the number of the first and the last sheets;
(e) a list of registered addicts and preparations, indicating the leaf numbers reserved for the registration of each substance and preparation; the obligation to indicate the number of sheets reserved for the registration of individual addictive substances and preparations does not apply to the records in the pharmacy.
(2) Registration books may be kept separately for individual branches of legal entities or activities.
(3) The records shall be entered in the registers on the date on which the recorded event occurred and, unless otherwise specified, signed by the person who made the entry.
(4) Corrections to the records shall be made in such a way as to determine the contents of the original record. The corrected alert shall be dated and signed by the person who corrected the alert.
Electronic registration
(1) Electronic records shall be kept in such a way as to allow for separate daily monitoring of movements and stocks and their traceability for 5 years.
(2) The electronic registration shall ensure that entries in the register are made only by persons authorised to do so, with the possibility of identifying the person who made the registration for a period of 5 years.
(3) Electronic records may be kept separately for each organisational component or activity.
(4) Records shall be entered in the electronic register on the date on which the recorded event occurred.
(5) In the case of electronic records, it is necessary to ensure that the records allow for the execution of an immediate print output that correctly displays all the required facts over a controlled period.
(6) Electronic records shall be made:
(a) once a day a security copy of the data file;
(b) at least every six months, a archive copy of a data file on a non-descriptive storage medium with a manufacturer's guaranteed registration life of 5 years or an advance of a data file from which data can be reconstructed, kept on a data carrier different from the hardware equipment used to maintain electronic records.
(7) Unless otherwise specified, electronic records shall contain the following information:
(a) the name of the preparation, including its strengths (3), pharmaceutical form and package size,
(b) the date of receipt;
(c) the date of issue;
(d) the number of the receipt document;
(e) the number of the proof of issue,
(f) the lot number,
(g) the name and, where applicable, the names and surname or registered office of the supplier;
(h) the name and, where appropriate, the names of the consignee and the surname or registered office;
(i) the quantity accepted;
(j) the quantity issued;
(k) unit quantity,
(l) stocks,
(m) the identification of the person making the registration.
Inventory
(1) Inventory in the records shall be carried out monthly ("monthly inventory") on the last day of the calendar month, even if there has been no record of movement during the calendar month. If the last day of the calendar month is Saturday, Sunday or Saturday 15), the monthly inventory may be made on the next working day.
(2) The monthly inventory shall be recorded in the register for all the items monitored, indicating the inventory date and the signatures of the persons who carried out the inventory. The monthly inventory record shall include:
(a) the initial state of the reference period;
(b) total revenue,
(c) total output; and
(d) the situation on the last day of the calendar month.
(3) If no movement has occurred during the reference period, the word "Status unchanged 'shall be entered in the record of the monthly inventory, the date of the inventory and the signatures of the persons carrying out the inventory.
(4) An electronic inventory shall be made on the last day of the calendar quarter (hereinafter referred to as "quarterly inventory '), unless otherwise specified. If the last day of the calendar month is Saturday, Sunday or Saturday 15), the quarterly inventory may be made on the next working day. A record shall be made of the quarterly inventory, which shall be drawn up in paper form and shall contain the following particulars for all items monitored:
(a) the initial state of the reference period;
(b) total revenue,
(c) total output; and
(d) the situation at the last day of the calendar quarter.
(5) The inventory record shall also include the date, name, function and signatures of the persons who carried out the inventory.
(6) If the difference between the actual and the accounting status is ascertained in the monthly or quarterly inventory, an inventory report shall be drawn up indicating the differences identified, their justification, the date, name, function and signatures of the persons who carried out the inventory, including the responsible person, where specified.
EVIDENCE FOR PERSONS ESTABLISHING COUPLING PRODUCTS AND PREPARATIONS
Registration in the manufacture of addictive substances and preparations
(1) The records for the manufacture of addictive substances and preparations shall be treated mutatis mutandis in accordance with Sections 1, 2 and 4.
(2) In the manufacture of addictive substances and preparations, records of all production activities occurring during manufacture shall be kept in the register.
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation, including its strengths (3), pharmaceutical form and package size,
(b) the name of a substance which is not an addictive substance but will be used for the manufacture of a substance;
(c) the serial number of the registration;
(d) the date on which the substance and preparation are taken over from storage;
(e) the date on which the substance is taken from the warehouse which is not an addictive substance but will be used for the manufacture of the substance;
(f) the quantity of the substance in grams and preparation in the number of packages or per formulation, such as tablets, ampoules, taken from storage;
(g) the quantity of substance in grams which is not an addictive substance but will be used for the production of the substance taken from storage;
(h) the production batch number,
(i) the date of transmission of the finished substances and preparations to the warehouse in grams or in number of packages;
(j) the quantity of finished substances and preparations delivered to the warehouse in grams or in number of packages;
(k) actual production losses in grams or in number of packages or per formulation;
(l) waste resulting from manufacture in grams or in number of packages or in number of individual formulations;
(m) the name and, where applicable, the name and surname, function and signature of the official carrying out the registration.
Registration for substance and preparation research
(1) The records of substance and preparation research shall be treated mutatis mutandis in accordance with Sections 1, 2 and 4.
(2) The registration of substance and preparation research shall include the name of the project or objective of the research activity. A separate register shall be kept for each research project or objective.
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation;
(b) the name of a substance which is not an addictive substance but will be used for research into the production of a substance;
(c) the serial number of the registration;
(d) the date of use of the substance, preparation or substance which is not an substance but will be used for research into the production of the substance;
(e) the quantity of the substance, preparation or substance used, which is not an substance but will be used for research into the production of the substance;
(f) the number of the experiment or other identification of the substance or preparation produced;
(g) the way in which an addictive substance, a preparation or a substance which is not an addictive substance is consumed but will be used for research into the production of the substance;
(h) the name and, where appropriate, the names and surname, function and signature of the official carrying out the registration.
Storage records with the manufacturer or distributor
(1) The storage register for the production4) or distribution5) shall be treated mutatis mutandis in accordance with Sections 1 to 4.
(2) In the case of storage for products4) or distribution5) addictive substances and products containing addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordination12), the register records are kept in the register, with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on addictive substances 12) and also in Annex 8 to the Government Ordinance on addictive substances 12).
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation, including its strengths (3), pharmaceutical form and package size,
(b) the date of receipt;
(c) the date of issue;
(d) the number of the receipt document;
(e) the number of the proof of issue,
(f) the batch number and, where applicable, the test number, if any, provided;
(g) the name and, where applicable, the names and surname or registered office of the supplier;
(h) the name and, where appropriate, the names of the consignee and the surname or registered office;
(i) the quantity accepted;
(j) the quantity issued;
(k) unit quantity; and
(l) stocks.
(4) The storage shall also keep records of products containing addictive substances listed in Annexes 2, 6 or 7 to the Government Ordinance on the List of addictive substances (12), or of products containing addictive substances listed in Annex 1 to the Government Ordinance on the List of addictive substances (12) and, at the same time, of Annex 8 to the Government Regulation on the List of addictive substances (12), or of medicinal products containing that substance, category 113). In this case, electronic records may be kept. Electronic records shall contain the information referred to in paragraph 3.
Records where addictive substances and preparations are not stored
(1) The registration of addictive substances and preparations in cases where they are not stored shall be treated mutatis mutandis in accordance with Sections 1 to 3.
(2) The registration of addictive substances and preparations containing addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordinance on the List of Addiction12) shall be kept in the register, with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on the List of Addiction12) and also in Annex 8 to the Government Ordinance on the List of Addiction12).
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation, including its strengths (3), pharmaceutical form and package size,
(b) the date of delivery and the date of issue;
(c) the number of the proof of delivery and of delivery;
(d) the batch number and, where appropriate, the test number, if they are indicated,
(e) the name and, where appropriate, the names of the supplier and the surname or registered office;
(f) the name and, where applicable, the names and surname or registered office of the purchaser;
(g) quantities delivered and issued; and
(h) unit quantity.
(4) In cases where products are not stored, the records of products containing addictive substances listed in Annexes 2, 6 or 7 to the Government Ordinance on the lists of addictive substances (12) or those containing addictive substances listed in Annex 1 to the Government Regulation on the lists of addictive substances (12) shall also be kept and listed in Annex 8 to the Government Regulation on the lists of addictive substances (12) or medicinal products containing that substance, category 113). In this case, electronic records may be kept. Electronic records shall contain the information referred to in paragraph 3.
Registration at the pharmacy
(1) The records at the pharmacy shall be treated mutatis mutandis in accordance with § 1 to 4.
(2) The pharmacy shall keep records of addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordinance on Rates of Rates (12) and preparations containing these substances, with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on Rates (12) and listed in Annex 8 to the Government Ordinance on Rates (12) in the register or in the form of electronic records.
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the substance or preparation, including its strengths (3), pharmaceutical form and package size,
(b) column numbers,
(c) the serial number of the document,
(d) the date of receipt;
(e) the date of issue;
(f) the name and, where appropriate, the name and surname of the doctor and the name, registered office of the prescribing health service provider and the name and, where appropriate, the name and address of the patient's place of residence and, if there is no permanent residence, the address of the patient's residence at the time of issue;
(g) the name and, where appropriate, the names and the surname and address of the supplier on receipt;
(h) unit quantity,
(i) the quantity accepted; and
(j) the quantity issued.
(4) The electronic registration referred to in paragraph 2 shall contain the following information:
(a) the name of the substance or the name of the preparation, including its strengths (3), the pharmaceutical form and the packaging size;
(b) the date of receipt;
(c) the date of issue;
(d) the name and, where applicable, the names of the doctor and the name and address of the prescribing health service provider at issue;
(e) the name and, where applicable, the names and surname and address of the patient's permanent residence and, if he is not resident, the address of the patient's residence at the time of issue;
(f) the electronic recipe identifier at issue;
(g) the name and, where appropriate, the names and surname or registered office of the supplier upon receipt;
(h) the number of the receipt document;
(i) unit of quantity;
(j) the quantity accepted;
(k) the quantity issued,
(l) current stocks,
(m) the name and, where appropriate, the names and surnames of the person making the entry; and
(n) a qualified electronic signature of the person making the registration.
(5) The pharmacy shall also keep records of addictive substances listed in Annexes 2, 6 and 7 to the Government Ordinance on the lists of addictive substances (12), products containing these substances and medicinal products containing that substance in category 113) using the data contained in the register under the specific legislation14). In this case, electronic records may be kept. Electronic registration shall include the following information:
(a) the name of the substance or the name of the preparation, including its strengths (3), the pharmaceutical form and the packaging size;
(b) the date of receipt;
(c) the date of issue;
(d) the number of the receipt document;
(e) the quantity accepted;
(f) the quantity issued,
(g) current stocks; and
(h) identification of the person who made the entry.
(6) Where electronic records are kept of addictive substances listed in Annex 1, 3, 4 or 5 to the Government Ordinance on the lists of addictive substances (12) and preparations containing these substances, a monthly inventory shall be made under the conditions set out in the second sentence of Article 4 (4). Where the electronic records referred to in paragraph 5 are kept, the inventory referred to in Article 4 (4) shall not be carried out.
(7) In the case of electronic records, it is necessary to ensure that the record allows the immediate single electronic output to be made in the .xml format, which correctly displays all the facts required by this decree during the reference period. At the same time, it is necessary to ensure that records allow a uniform print output.
(8) Where the register is kept in electronic form in accordance with paragraph 2 or 5, the person operating the pharmacy shall keep the data media referred to in paragraphs 13 and 15 containing the information referred to in paragraph 4 or 5. The person operating the pharmacy shall ensure regular backup of the data from which the data kept in the register can be reconstructed. The person operating the pharmacy shall ensure the backup of data on media different from the hardware equipment used to keep electronic records. Backup shall be carried out according to a predetermined schedule by the person operating the pharmacy, but without undue delay after the closing of the operating day.
(9) The person operating the pharmacy shall draw up and maintain the organisational and technical security of the electronic record keeping referred to in paragraph 2 in a written form, in which he shall lay down at least:
(a) conditions for access by users to the record keeping system, the scope of access rights and the setting-up process, including how to decide on the scope of access rights of individual users and decide on their changes;
(b) the procedure and timing of the data backup referred to in paragraph 8;
(c) the procedure for the reconstruction of data kept in the back-up data register;
(d) the way documents are kept;
(e) the procedure for dealing with situations where the functions of the record keeping system are malfunctioning, including the way in which the replacement operation is ensured;
(f) a procedure for dealing with a situation where the means used to keep records under contract with another person cannot be used anymore;
(g) the error correction procedure in the register and the content of the record of the correction carried out, including the traceability of the original record;
(h) the manner in which users are trained and the way in which documentation of the training carried out is kept.
Registration by a health service provider not mentioned in § 8 and a social residence service provider
(1) The register kept with the health service provider not mentioned in § 8 and with the resident social service provider shall be treated mutatis mutandis in accordance with § 1, 2 and 4.
(2) The health service provider not referred to in § 8 and the residence social service provider shall keep records of products containing addictive substances listed in Annexes 1, 3, 4 or 5 to the Government Ordinance on addictive lacquers (12) in the register books, with the exception of products containing addictive substances listed in Annex 1 to the Government Ordinance on addictive lacquers (12) and also listed in Annex 8 to the Government Ordinance on addictive little12).
(3) The register referred to in paragraph 2 shall contain the following records:
(a) the name of the preparation, including its strengths (3), pharmaceutical form and package size,
(b) the date of receipt;
(c) the date of issue;
(d) a series of blocks, a request number and the name and registered office of the supplier upon receipt;
(e) the number of the medical file and the name and surname, if any, and the date of birth of the patient at the time of issue (submission to the patient),
(f) the signature of the doctor or health care professional concerned,
(g) the quantity accepted;
(h) the quantity issued;
(i) unit of quantity;
(j) stocks.
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Regulation Information
| Citation | Decree No. 123 / 2006 Coll., on the registration and documentation of addictive substances and preparations |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 06.04.2006 |
|---|---|
| Effective from | 01.05.2006 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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