71/2014 Sb.
DECREE
of 8 March. April 2014
on the content, form and terms of keeping records of activities with the
substance category 1
The Ministry of health shall lay down pursuant to § 53 para. 2 to implement section 30
paragraph. 1 Act No. 272/2013 Coll., on drug precursors, (hereinafter referred to as
the "Act"):
§ 1
The subject of the edit
This Decree regulates the following on directly applicable provisions of
^ 1 of the European Union) table of contents, form and requirements for keeping records of income and
issue, mediation and the production of scheduled substances of category 1 (hereinafter referred to as
"listed substance").
§ 2
The concepts of
For the purposes of this Ordinance, means the
and the intake of those substances), physical receipt listed substances to the inventory, including
income from another site skladujícího, in particular from the lab, another
warehouse or production plants,
(b) the issue of listed substances), physical issue from inventory, including those substances
issues to another site skladujícího, and in particular to the lab, another
warehouse or production plants,
(c) the provision of scheduled substances)
1. provision of scheduled substances from the supplier to the customer, if this
that substance leaves the customs territory of the European Union and the provider
This substance stored anywhere; mediation is not a mere
provision of opportunities to the conclusion of the agreement between the supplier and
the customer, or
2. Agency services by directly applicable legislation
The European Union on the establishment of rules for monitoring trade in scheduled
substances between the European Union and third countries ^ 2).
§ 3
Registration book and its essentials
(1) on the intake and delivery, mediation or the production of materials
records lead in writing in the registration book.
(2) records for the production of those substances shall be kept separately for each
workplace in which to manufacture the substance, even though it was just a
a subset of the intended activity in the production process. Records on the receipt and
supply scheduled substances shall be kept separately for each warehouse.
(3) the Registration book can be used to keep a record of one or more
activities with one or more of the listed substances, but for each
an individual activity or substance is in the registration book of the reserved
at least one separate sheet.
(4) Leaves the records are linked to each other, so that it was not possible
nerozpoznatelně single sheets cut, replace or insert. Each
list the records can have a detailed first hand. All sheets
the records must be numbered.
(5) in the introduction, the records shall show the
and) business name, the name and address of the registered office of the
activities shall be maintained in the registration book of records; If records are kept
separately for individual workplaces or is referred to a substance stored in
multiple warehouses, and the designation of the place of work or warehouse
(b) the name of the scheduled substance as given in) the annexes directly applicable regulations
The European Union on drug precursors ^ 3) and playing with her, about that
in the registration book of records; If the book is used for registration
record keeping for more activities with that substance or activity with
more of the scheduled substances, and numbers of worksheets are reserved for
individual activities or those substances,
(c)) the names, job title and the specimen signatures of the individuals in the
registration book records, or that perform the inventory, including
indication of the date on which the decision of whose activities are
lead in the registration book of the records may do,
(d)) the date from which the registration book is used to record-keeping, and
(e)) the total number of sheets of the records.
(6) after their record-keeping in the registration book of the particulars referred to in
paragraph 5 (b). (d) the date of such termination) and the first leaves
the records or parts thereof which have remained nepopsány,
diagonal be crossed out.
§ 4
The content of the record on the intake or supply of scheduled substances
(1) on the intake or supply of scheduled substances in the registration book shall
record from which it can be seen, whether it relates to income or issues, and that
contains
and) date of receipt or issue of that substance,
b) quantity received or issued, those substances
(c)) the document number on the intake or supply of scheduled substances,
d) lot and clearance of scheduled substances if they are indicated on the packaging referred to
substances or in the relevant documents,
e) data identifying enough vendor or customer, especially
first name, name and address, and
(f) the total quantity of the substance) in the warehouse after its receipt or
picking.
(2) if it is taken that substance used for the preparation of the medicinal
of ^ 4), the records also record of the name and the amount of
prepared by the medicinal product and the date of its issue or the patient
another customer.
§ 5
The contents of the record of the mediation referred to substance
The mediation materials in the accounting book will make a record
that contains the
and the delivery date scheduled substances) to the customer,
(b) the quantities of the scheduled substances) mediated,
(c) proof of delivery of) the number of scheduled substances to the customer and
(d) information sufficient to identify the vendor) and the customer.
§ 6
The content of the record on the production of those substances
About the manufacture of the substances referred to in the registration book shall record that
contains
and the date of manufacture, quantity) and batch number of the scheduled substance produced
(b) the name and amount of input) of the substance and the date of its entry into the production
the process and
c) deviation in quantity produced referred to substances and waste compared to
competent description of the production technology.
§ 7
Time and form of the record in the registration book
(1) record in the registration book shall be recorded in the day activities with
scheduled substance. The record must correspond to the actual state.
(2) each entry in the registration book has a serial number and is signed by the
the person who made it.
(3) if the registration book does not record the amount of substance in grams, it is
part of the record also the unit quantity.
(4) a bad record with repairs so that it remains legible. The corrected record is
be dated and signed by the repair person who corrected the record.
§ 8
Inventory
(1) compliance records in the records of receipt and issue materials
the actual quantity of the substance in the warehouse shall be checked once
monthly inventory. Inventory is always done on the last day
the calendar month.
(2) when counting the actual quantity of the substance in the warehouse compares
the sum of all the received quantities of that substance in the corresponding
calendar month, reduced by the sum of all quantities of the substance released
in the relevant calendar month enlisted in the registration book, and also with
an indication of the total quantity of the substance in the warehouse, registered in the
registration book under section 4 (4). 1 (b). (f)) in the context of the last record.
(3) a count shall be recorded in the registration book, usually
the last record of activity with the substance. For the time and form of
perform inventory record shall apply, mutatis mutandis, with article 7, that this
the record must be signed by the persons who carried out the inventory.
(4) The records shall be entered
and date of inventory)
(b)) total received and issued by the quantity of the substance in the
calendar month according to the records and the
(c) the actual quantity of the substance) in the warehouse of the last day
the relevant calendar month.
(5) If in a calendar month to avoid intake or supply referred to
substance, in the records of the book instead of the data referred to in paragraph 2 (a). (b)), and
(c)) shall be entered, the words "the status unchanged."
§ 9
Protocol on the detected non-compliance
(1) where persons who carried out the inventory referred to in section 8, this
inventory detects a mismatch between the records in the records and the actual
the quantity of the substance in the warehouse, the sepíší of this fact without delay
Protocol. In the log
and non-compliance is detected, including enumerations) differences,
(b) the grounds for the non-conformity recorded),
(c)) date of inventory that was a mismatch is detected, and
(d) the date of drawing up the Protocol.)
(2) the Protocol shall be signed by the person that actually made, and also the responsible
person, unless it was not in accordance with the directly applicable European law
Union ^ 5) appointed.
(3) the Protocol shall be kept as a record of activity with the substance.
§ 10
Final provision
This Decree was notified in accordance with the directive of the European Parliament
and Directive 98/34/EC of 22 December 2004. June 1998 on the procedure for the provision
information in the field of standards and technical regulations and rules on services,
the information society, as amended.
§ 11
The effectiveness of the
This Decree shall enter into force on 1 January 2000. may 2014.
Minister:
Mudr. Němeček, MBA, in r.
1) European Parliament and Council Regulation (EC) No 273/2004 of 11 March.
February 2004 on drug precursors, as amended.
Council Regulation (EC) No 111/2005 of 22 December 2004. 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 June. July 2005
detailed rules for the regulation of the European Parliament and of the Council (EC)
No 273/2004 on drug precursors and for 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) European Parliament and Council Regulation (EC) No 273/2004.
Council Regulation (EC) No 111/2005.
4) § 5 para. 3 of the law No 378/2007 Coll., on pharmaceuticals and on changes of some
related laws (law on medicinal products).
5) Article. 13 (a). b) Commission Regulation (EC) No 1277/2005.
