Decree No. 71 / 2014 Coll.
Order on the content, form and particulars of the record keeping of the activity with that category 1 substance
Valid
Effective from 01.05.2014
71
DECLARATION
of 8 April 2014
on the content, form and particulars of the record keeping of the activity with that category 1 substance
The Ministry of Health provides, pursuant to Section 53 (2), for the implementation of Section 30 (1) of Act No. 272 / 2013 Coll., on drug precursors ("the Act '):
Subject matter
This decree regulates the content, form and formalities of the records of the intake and supply, brokering and production of the scheduled substance of category 1 (hereinafter referred to as "the substance ') following the directly applicable European Union1.
Terms
For the purposes of this decree:
(a) the admission of the scheduled substance to a warehouse, including the admission from another warehouse, in particular from a laboratory, another warehouse or factory;
(b) the release of the scheduled substance by physical delivery from the warehouse, including delivery to another warehouse, in particular to a laboratory, another warehouse or factory;
(c) by brokering the scheduled substance,
1. the procurement of the scheduled substance by the supplier to the customer, unless the latter leaves the customs territory of the European Union and the intermediary does not store the scheduled substance; a contract between the supplier and the customer shall not be considered as mediation; or
2. Intermediate activity under the directly applicable European Union Regulation on the establishment of rules for the monitoring of trade in scheduled substances between the European Union and third countries (2).
Registration book and its particulars
(1) Records of the intake, supply, brokering or manufacture of the scheduled substance shall be kept in the register in writing.
(2) The production records of the scheduled substance shall be kept separately for each workplace where the production of the scheduled substance takes place, even if it is only a partial activity within the intended production process. Receipt and issue records of the scheduled substance shall be kept separately for each warehouse.
(3) The register may be used to record one or more activities involving one or more of the scheduled substances, but for each individual activity or scheduled substance at least one separate sheet is reserved in the register.
(4) The sheets of the register shall be bound together in such a way that it is not possible to remove, replace or insert individual sheets indistinguishable. Each sheet of the register can only be described on the first page. All sheets of the register must be numbered.
(5) The introduction of the register should include:
(a) the business name, name or address of the registered office of the person whose business is recorded in the register; if records are kept separately for each workplace or the substance is stored in several warehouses, the description of the workplace or warehouse shall also be provided;
(b) the name of the scheduled substance as specified in the Annexes to the directly applicable European Union drug precursor regulations (3) and the activity with it recorded in the register; if the register serves to record more activities with that substance or activities with more than one scheduled substance, the number of sheets reserved for each activity or scheduled substance shall be given;
(c) the names, working positions and signature models of natural persons who make records or carry out inventories in the register, including an indication of the date on which, by decision of the person whose activities are recorded in the register, they may do so;
(d) the date from which the register serves to keep records; and
(e) the total number of sheets of the register.
(6) On completion of the record keeping in the register, the date of such termination shall be added to the data referred to in paragraph 5 (d) and the first pages of the sheets of the register or parts thereof remaining unwritten shall be cut diagonally.
Content of the entry or issue of the scheduled substance
(1) A record shall be made of the intake or supply of the scheduled substance in the register showing whether it relates to the intake or supply and containing:
(a) the date of receipt or issue of the scheduled substance;
(b) the quantity of scheduled substance accepted or issued,
(c) the number of the document of receipt or issue of the scheduled substance;
(d) the batch numbers and the test of the scheduled substance, if they appear on the packaging of the scheduled substance or in related documents;
(e) data sufficiently identifying the supplier or customer, in particular the name, name and registered office; and
(f) the total quantity of scheduled substance in storage after receipt or delivery.
(2) If the substance received is used to prepare a medicinal product (4), the register shall also record the name and quantity of the medicinal product prepared and the date of issue to the patient or to another customer.
Content of the brokering record of the scheduled substance
An alert shall be made on the mediation of that substance in the register, which shall include:
(a) the date of delivery of the scheduled substance to the customer;
(b) the quantity of scheduled substance,
(c) the number of the proof of delivery of the scheduled substance to the customer; and
(d) an indication sufficiently identifying the supplier and the customer.
Content of the record of manufacture of that substance
A record shall be made of the manufacture of that substance in the register, which shall include:
(a) the date of manufacture, the quantity and the batch number of the scheduled substance produced;
(b) the name and quantity of the input substance and the date of its entry into the production process; and
(c) a derogation in the quantity of the scheduled substance and waste produced compared to the relevant description of the production technology.
Time and form of entry in the record book
(1) The entry in the register shall be made on the day of the recorded activity with that substance. The record must correspond to the actual state.
(2) Each entry in the register shall have a serial number and shall be signed by the person who made it.
(3) If the quantity of substance in grams is not recorded in the register, the unit of quantity shall also be included in the record.
(4) The error shall be corrected in such a way that it remains legible. The corrected alert shall be dated and signed by the person who corrected the alert.
Inventory
(1) The compliance of the entries in the entry and issue log of the scheduled substance with the actual quantity of scheduled substance in storage shall be verified once a month by inventory. The inventory shall be carried out on the last day of the calendar month.
(2) In the inventory, the actual quantity of scheduled substance in the stock shall be compared with the sum of all quantities received of scheduled substance in the relevant calendar month, minus the sum of all the quantities issued of that substance in the relevant calendar month, recorded in the register, as well as the total quantity of scheduled substance in the stock, recorded in the register referred to in Article 4 (1) (f) in the last entry.
(3) The inventory shall be recorded in the register, usually behind the last record of the activity with that substance. Paragraph 7 shall apply mutatis mutandis to the time and form of the inventory record, with the entry being signed by the persons who made the inventory.
(4) The register shall be entered in:
(a) the date of the inventory,
(b) the total quantity of scheduled substance accepted and issued in the relevant calendar month, in accordance with the register; and
(c) the actual quantity of scheduled substance in storage on the last day of the calendar month concerned.
(5) If there is no income or expenditure of the scheduled substance in the calendar month, the words "Status unchanged 'shall be entered in the register instead of the particulars referred to in paragraph 2 (b) and (c).
Protocol on found non-compliance
(1) If the persons who have carried out the inventory pursuant to Article 8 find that the inventory does not conform to the records in the register and the actual quantity of the scheduled substance in the warehouse, they shall immediately write a record thereof. The Protocol shall state:
(a) the mismatch found, including quantification of differences;
(b) justification for the non-compliance found;
(c) the date of the inventory which has been found to be inconsistent; and
(d) the date on which the Protocol is drawn up.
(2) The Protocol shall be signed by the persons who have drawn up the Protocol and also by the responsible person, unless it has not been appointed in accordance with the directly applicable European Union Regulation (5).
(3) The Protocol shall be kept as a record of the activity with that substance.
Final provision
This Decree was notified in accordance with Directive 98 / 34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services, as amended.
Efficacy
This Decision shall enter into force on 1 May 2014.
Minister:
MUDr.
1) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council of 11 February 2004 on drug precursors, as amended. Council Regulation (EC) No 111 / 2005 of 22 December 2004 laying down rules for the monitoring of trade in drug precursors between the Community and third countries, as amended. Commission Regulation (EC) No 1277 / 2005 of 27 July 2005 laying down detailed rules for the application of Regulation (EC) No 273 / 2004 of the European Parliament and of the Council on drug precursors and Council Regulation (EC) No 111 / 2005 laying down rules for the monitoring of trade in drug precursors between the Community and third countries, as amended.
2) Council Regulation (EC) No 111 / 2005.
3) Regulation (EC) No 273 / 2004 of the European Parliament and of the Council. Council Regulation (EC) No 111 / 2005.
4) Article 5 (3) of Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines).
5) Article 13 (b) of Commission Regulation (EC) No 1277 / 2005.
Sign in for notes, favorites and notifications
Regulation Information
| Citation | Decree No. 71 / 2014 Coll., on the content, form and particulars of record keeping of activity with that category 1 substance |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 14.04.2014 |
|---|---|
| Effective from | 01.05.2014 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
Comments 0