123/2006 Sb.
The DECREE
of 31 March 2004. March 2006
about the recording and documentation of addictive substances and preparations
Change: 72/2014 Sb.
The Ministry of health shall lay down pursuant to § 32 paragraph. 3 and § 33 paragraph. 2
Act No. 167/1998 Coll., on addictive substances and amending certain
other laws, as amended by law No 117/2000 Coll., Act No. 362/2004 Sb.
and Act No. 74/2006 Coll. (hereinafter the "Act"):
PART THE FIRST
EVIDENCE OF ADDICTIVE SUBSTANCES AND PREPARATIONS
TITLE I OF THE
COMMON PROVISIONS FOR THE REGISTRATION OF SUBSTANCES AND PREPARATIONS AND ON THE
INVENTORIED
§ 1
Registration Essentials
(1) Evidence of treatment, the import and export of addictive substances and preparations
with their content (hereinafter referred to as "the register") leads in writing in bound
books with numbered sheets (hereinafter "registration"). The register can be
lead in the cases provided for in this Decree (hereinafter referred to as electronically
"electronic record").
(2) the register is always leads completely and in accordance with this Decree, so that
true to display the fact that they are the subject. The consistency of the
registers with the actual status in the registers or
management of electronic records verifying inventory.
(3) to indicate the name of the addictive substances referred to in regulation of the Government of
substance lists ^ 12), medicinal products "^ 1") to indicate their
registered name ^ 2).
§ 2
Accounting books
(1) the registration book in addition to the custom registers in accordance with title II of the
always contains
and the name, business name) or the name and address of the person, which leads
records, including designation and address of the establishment where it is actually
work with substances and preparations, which is subject to registration
pursuant to the Act and this order, if the address of that establishment is different
from the address of the registered office,
(b) the name, if applicable) names of natural persons that write registration
records in the records, their residence and specimen signature (hereinafter referred to as
"signature"), and the date from which such persons shall carry out the accounting records,
(c)) date of transmission of the records into the application and their use,
(d)), the total number of sheets, indicating the first and last numbers worksheet
(e) a list of the registered substance abuse) and of the products with an indication of the numbers
leaves reserved for registration of individual substance abuse and
preparations; the obligation of placing sheets of numbers reserved for registration
each of the addictive substances and preparations shall not apply to the registration
books in the pharmacy.
(2) the records may be kept separately for each
legal persons or organisational units for individual activities.
(3) the accounting records shall be entered in the records on the day, when
There was registered the fact, and, if not stated otherwise, be
with the signature of the person who carried out the registration.
(4) Repair records records shall be carried out so as to make it possible to determine
the content of the original record. The corrected record shall be dated and signed by the
the person who conducted repair record.
§ 3
Electronic register
(1) the electronic register is leads to allow separate daily
motion tracking and State of the stocks and their findings back for 5 years.
(2) in the electronic records is necessary to ensure that the entries in the
registration are carried out only by persons authorised to do so with the understanding that it is necessary to
to ensure the possibility of identification of the person who made the registration for a period of
5 years.
(3) electronic register can be conducted separately for each
organizational folder or for individual activities.
(4) the accounting records to the electronic record shall be entered in the day
There was registered the fact.
(5) in the electronic records is necessary to ensure that registration
allow the implementation of immediate print output, which truthfully
Displays all the required facts for the period checked.
(6) in the electronic register shall be effected
and once daily safety copy) data file
(b)) twice a year, archived copy of the data file on nepřepisovatelném
storage medium with the manufacturer guaranteed lifetime registration for 5 years.
(7) electronic record includes, unless stated otherwise, these
information:
and the name of the product), including its power ^ 3), pharmaceutical form and size
packaging,
(b) the date of receipt),
(c)) date of issue
(d) the document number on the receipt),
(e)) the document number on the issue,
f) batch number
(g) the name and place of residence) or the name and address of the supplier,
(h) the name and place of residence) or the name and address of the recipient,
I) quantity received,
(j)), the amount of issued
the unit of quantity)
l) stocks,
m) identification of the person writing.
§ 4
Inventory
(1) Inventory in the registers shall be carried out on a monthly basis (hereinafter referred to as
"the monthly inventory") to the last day of the calendar month, even if
during the calendar month that there was no record of the movement.
(2) the implementation of a monthly inventory of all tracked items
recorded in the registration book with indicating the date and signatures of the persons inventory,
that inventory. In the record of the implementation of the monthly inventory
shall indicate the
and the initial state of the reference period),
(b)), the total income,
(c)) the total supply and
(d) the date of inventory).
(3) If in the reference period there was no motion shall be in
record on the implementation of the monthly inventory, the words "the status unchanged", date
inventory and signatures of the persons that carry out inventory.
(4) in the electronic records of the inventory shall be carried out on the last day
the calendar quarter (hereinafter referred to as "the quarterly inventory"), if it is not
stated otherwise. On the implementation of the quarterly inventory shall record the
implementation of inventory, which shall be made in documentary form and contains the
all monitored items the following particulars:
and the initial state of the reference period),
(b)), the total income,
(c)) the total supply and
(d) the date of inventory).
(5) a record of the count also contains the date, name, function and
signatures of the persons that carry out the counting.
(6) if it is established at monthly or quarterly inventory report the difference between the
the real and the registration status, a counting Protocol in which
shall the differences, their justification, date, name,
the function and the signatures of the persons who have carried out an inventory including responsible
the person is appointed.
TITLE II
THE REGISTRATION OF WORKING PERSONS WITH ADDICTIVE SUBSTANCES AND PREPARATIONS
§ 5
Registration in the production of addictive substances and preparations
(1) when you register in the production of addictive substances and preparations shall be treated
under section 1, 2 and 4.
(2) the production of addictive substances and preparations in the registration book of the lead
the accounting records of all production activities, including during production
occurs.
(3) the records referred to in paragraph 2, the book contains the following records:
and addictive substances or) the name of the product, including its power ^ 3), pharmaceutical
the form and the size of the packaging,
(b)) name of the substance is not an addictive substance, but will be used for
production of addictive substances
(c) the serial number of the registration)
(d)) date of taking addictive substances and product from the warehouse,
(e) the date of the takeover of the substance) of the warehouse, which is not an addictive substance, but
will be used for the production of addictive substances
(f) the quantity of substance in) grams, and the number of the product in the package or in the
the number under each dosage forms such as tablets, ampoules,
taken from the warehouse,
(g) the quantity of the substance in grams), which is not an addictive substance, but will
used for the production of addictive substance, taken from the warehouse,
(h)) the production batch number,
I) date of the transmission of finished drugs and preparations to the warehouse in
grams or number of packages,
(j) the quantity of substance transmitted finished) substances and preparations in the warehouse in
grams or number of packages,
the actual losses in production) grams or number of packages or number of
According to individual dosage forms,
l) waste generated in the production of in grams or in the number of packages or number of
According to individual dosage forms,
m) name, capacity and signature of the worker performing the registration.
§ 6
The evidence in storage by manufacturer or distributor
(1) when you register for storage by manufacturer or Distributor ^ 4) ^ 5)
in accordance with § 1 to 4.
(2) during storage at the producer or Distributor ^ 4) ^ 5), substance abuse and
preparations containing addictive substances listed in the annexes 1, 3, 4
or 5 Government regulation of addictive drugs ^ 12) lead
the accounting records in the records book, with the exception of products containing
addictive substances listed in the annex No. 1 of the regulation of the Government of
substance abuse ^ 12) and at the same time as referred to in Annex i, no 8 of the regulation of the Government
the substance lists ^ 12).
(3) the records referred to in paragraph 2, the book contains the following records:
and addictive substances or) the name of the product, including its power ^ 3), pharmaceutical
the form and the size of the packaging,
(b) the date of receipt),
(c)) date of issue
(d) the document number on the receipt),
(e)) the document number on the issue,
(f) the number of the batch where appropriate) clearance, if given,
(g) the name and place of residence) or the name and address of the supplier,
(h) the name and place of residence) or the name and address of the recipient,
I) quantity received,
(j)), the amount of issued
the quantity and unit)
l) inventory status.
(4) when the storage is also leads the registration of preparations containing addictive
substances referred to in annexes 2, 6 or 7 of the Government regulation of lists
substance abuse ^ 12) or preparations containing addictive substances listed
in annex No. 1 of the regulation of the Government of the substance lists ^ 12) and
at the same time as referred to in the annex to Regulation No 8 of the Government about the substance lists
^ 12) substances or medicinal products containing substances listed in category
1 ^ 13). In this case, you can have an electronic record. Email
the register contains the information referred to in paragraph 3.
section 7 of the
The evidence in the cases when the addictive substances and preparations are not stored
(1) when the registration of substances and preparations in the cases when they are not
stored, proceed according to section 1 to 3.
(2) When the registration of substances and preparations containing addictive
substances listed in the annexes 1, 3, 4 or 5 of the regulation the Government about lists
substance abuse ^ 12) accounting records shall be kept in the records book, with
except preparations containing addictive substances listed in the annex No. 1.
Government regulation of addictive drugs ^ 12) and at the same time as referred to in
Annex No. 8 Government regulation of addictive drugs ^ 12).
(3) the records referred to in paragraph 2, the book contains the following records:
and addictive substances or) the name of the product, including its power ^ 3), pharmaceutical
the form and the size of the packaging,
(b)) the delivery date and issue date,
(c) the delivery document number) and dispatch
(d) the number of the batch where appropriate) clearance, if given,
(e) the name and place of residence) or the name and address of the supplier,
(f) the name and place of residence) or the name and address of the customer
(g)) and issued by the amount and
h) unit of quantity.
(4) in cases where the products are stored, the evidence leads
preparations containing addictive substances referred to in annexes 2, 6 or
7 Government regulation of addictive substances or preparations ^ 12)
containing addictive substances listed in the annex No. 1 of the regulation of the Government of
substance lists ^ 12) and at the same time as referred to in annex No. 8
Government regulation of addictive drugs ^ 12) or medicinal products
containing substances listed in category 1 of the ^ 13). In this case, you can lead
the electronic register. Electronic register containing the information referred to in
of paragraph 3.
§ 8
Registration in pharmacy
(1) when you register at the pharmacy, according to § 1 to 4.
(2) the pharmacy shall maintain accounting records about addictive substances referred to
in the annexes, no. 1, 3, 4 or 5 of the regulation the Government about the substance lists
substances ^ 12) and preparations containing such substances in a registration book, with
except preparations containing addictive substances listed in the annex No. 1.
Government regulation of addictive drugs ^ 12) and at the same time as referred to in
Annex No. 8 Government regulation of addictive drugs ^ 12).
(3) the records referred to in paragraph 2, the book contains the following records:
and addictive substances or) the name of the product, including its power ^ 3), pharmaceutical
the form and the size of the packaging,
(b) the numbers of the columns),
(c) the serial number of document),
(d) the date of receipt),
(e)), issue date,
(f) the name of the doctor) and name and address of the prescribing provider
health services and the name and residence of the patient in,
(g) the name and place of residence) or the name and address of the supplier upon receipt,
(h)), the unit of measure
I) quantity received and
(j) the quantity issued.)
(4) in pharmacy leads evidence of addictive substances listed in
Annexes 2, 6 and 7 of the Government regulation of addictive drugs ^ 12)
preparations containing these substances and medicinal products containing
scheduled substances of category 1 ^ 13) using the data provided in the register
under special legislation ^ 14). In this case, you can lead
the electronic register. Electronic register contains the following information:
and addictive substances, name)
(b) the name of the product), including its power ^ 3), pharmaceutical form and size
packaging,
(c)) date of receipt,
(d)), issue date,
e) document number on the receipt,
f) quantity received,
(g) the quantities issued,)
(h)), the current status of stocks and
I) name of the person writing.
(5) if it is registered in accordance with paragraph 4, not counting
According to the section 4, paragraph 4. 4.
(6) if the record referred to in paragraph 4, must keep pharmacy rack
data (section 13), containing the information referred to in paragraph 4.
§ 9
The evidence led by the provider of health services not specified in § 8
provider of residential social services
(1) the register kept by the provider of health services not covered by
in section 8 and in residential social services providers as
section 1, 2 and 4.
(2) the provider of health services not covered by section 8 and
provider of residential social services accounting records are kept
preparations containing addictive substances listed in the annexes 1, 3, 4
or 5 Government regulation of addictive drugs ^ 12) in accountancy
the books, with the exception of preparations containing addictive substances listed in
Annex No. 1 to the Government about the substance lists ^ 12) and at the same time
referred to in the annex to Regulation No 8 of the Government about the substance lists
substances ^ 12).
(3) the records referred to in paragraph 2, the book contains the following records:
and the name of the product), including its power ^ 3), pharmaceutical form and size
packaging,
(b) the date of receipt),
(c)) date of issue
(d)), the number of the requested block series and the name and address of the supplier upon receipt,
(e) medical documentation and number) the name and, where applicable, the date of birth
the patient's issue (submission to the patient),
(f) the signature of the physician or competent) medical worker
g) quantity received,
(h) the quantities issued,)
I) unit of quantity,
j) inventory status.
§ 10
Registration in the provision of animal health care
(1) when you register in the provision of health care to proceed under section
1, 2 and 4.
(2) in the provision of health care to lead the accounting records in
the registration book for the treatment of addictive substances and preparations
containing addictive substances listed in the annexes 1, 3, or 5 of regulation
Governments on the list substance abuse ^ 12), with the exception of
containing addictive substances listed in the annex No. 1 of the regulation of the Government of
substance lists ^ 12) and at the same time as referred to in annex No. 8
Government regulation of addictive drugs ^ 12).
(3) the records referred to in paragraph 2, the book contains the following records:
and the name of the product), including its power ^ 3), pharmaceutical form and size
packaging,
(b) the date of receipt),
(c)) date of issue
(d) the document number on the receipt),
(e)) the document number on the issue,
(f) the number of the batch where appropriate) clearance, if given,
(g) the name and place of residence) or the name and address of the supplier,
(h) the name and place of residence) or the name and address of the recipient,
I) name and address or the name and address of the keeper,
j) quantity received,
quantities issued to),
l) quantity consumed,
m) unit of quantity,
n) inventory status.
§ 11
Registration in the activities of State authorities, territorial self-governing units and
other persons
(1) when you register in the activities of State authorities, local government
units, and other persons referred to in section 5 (3). 6 the Act is progressing according
section 1, 2 and 4.
(2) for the treatment of addictive substances and preparations with their content,
If this is not a procedure in accordance with section 9 or by section 12, shall be persons
referred to in section 5 (3). 6 of the Act shall keep accounting records in the records book.
(3) the records referred to in paragraph 2, the book contains the following records:
and addictive substances or) the name of the product, including its power ^ 3), pharmaceutical
the form and the size of the packaging,
(b) the date of receipt),
(c)) date of issue
(d) the document number on the receipt),
(e)) the document number on the issue,
(f) the number of the batch where appropriate) clearance, if given,
(g) the name and place of residence) or the name and address of the supplier,
(h) the name and place of residence) or the name and address of the recipient,
I) quantity received,
(j)), the amount of issued
to the amount consumed),
l) unit of quantity,
m) inventory status.
§ 12
Registration for listed persons
(1) when you register for the persons listed in section 5 (3). 7 of the Act shall
under section 1, 2 and 4.
(2) for the treatment of addictive substances, preparations containing addictive
substances listed in the annexes 1, 3, 4 or 5 of the regulation the Government about lists
substance abuse ^ 12), with the exception of preparations containing addictive substances
listed in annex No. 1 of the regulation of the Government of the substance lists ^ 12)
and at the same time as referred to in Annex i, no 8 of the regulation of the Government of
substance abuse ^ 12), lead by the persons listed in section 5 (3). 7
Act registration records in the records book.
(3) the records referred to in paragraph 2, the book contains the following records:
and addictive substances or) the name of the product, including its power ^ 3), pharmaceutical
the form and the size of the packaging,
(b) the date of receipt),
(c)) date of issue
(d) the document number on the receipt),
(e)) the document number on the issue,
(f) the number of the batch where appropriate) clearance, if given,
(g) the name and place of residence) or the name and address of the supplier,
(h) the name and place of residence) or the name and address of the recipient,
I) quantity received,
(j)), the amount of issued
to the amount consumed),
l) unit of quantity,
m) inventory status.
PART THE SECOND
DOCUMENTATION OF ADDICTIVE SUBSTANCES AND PREPARATIONS
section 13
Types of documentation
(1) documentation of the treatment of addictive substances and preparations make up
and records)
(b)) data carriers containing electronic data,
(c) implementation of the inventory records) from the inventories referred to in section 4, including
counting protocols from the inventories carried out under a special legal
Code ^ 7),
(d)) of the transmission of addictive substances registrations and preparations for the removal and
the minutes of the removal of addictive substances and preparations and other documents
concerning the removal of (section 14 of the Act),
(e)) about the loss or destruction of the protocols of addictive substances and preparations,
(f)) minutes on the examinations (section 34 of the Act),
g) all official decisions, including concerning the treatment of foreign
with addictive substances and preparations and on export and import of poppy concentrate,
(h) a copy of the report) (sections 26 to 30 and section 43 of the Act),
I) packing slips, invoices, and other documents on the intake and delivery of addictive
substances and preparations including relevant customs documents,
j) proof of purchase, sale or disposal of tabletovačky, dražovacího
boilers and boiler granulačního.
(2) the pharmacy shall be retained in addition to the documents referred to in paragraph 1
and the first copy of recipes) ^ 8) and request ^ 9) with a blue stripe, as well as
the first batches of recipes ^ 8) with blue stripe (section 13, paragraph 2, of the Act), if the
preparations paid by the patient,
(b)) data carriers containing the records to send electronic information
made on the issue, an electronic prescription (section 13 (1) of the Act)
the central store of electronic recipes.
(3) the provider of health services not covered by section 8 and
provider of residential social services shall be kept next to the
the documentation referred to in paragraph 1
and the second copy used), all recipes ^ 8) with a blue stripe and the first
leaves, and all of the second and third copy request forms used ^ 9) with blue
stripe (section 13, paragraph 2, of the Act),
(b)) data carriers containing records of identification issued by the
electronic prescriptions (article 13, paragraph 1, of the Act).
§ 14
Logs and records
Protocols, minutes and documents referred to in section 13 (3). 1 (a). (c)), d), (e)), f) and the
(j)) shall be signed by the responsible person always, if established. In the other
cases, the signs of these protocols, the minutes and the documents to the designated officer.
§ 15
Retention of documentation
(1) the documentation will be kept so as to prevent its spoilage,
loss, damage, destruction, misuse or theft. If this is a
storage of personal data, it shall proceed according to a special legal
^ Regulation 11).
(2) the documents relating to the treatment of addictive substances and
preparations with their content is kept for a period of 5 years (§ 33 (1)
the law) from the acquisition of the document, or from the last record in it
whichever of these facts occurred later.
PART THE THIRD
CANCELLATION AND FINAL PROVISIONS
section 16 of the
Cancellation provisions
Shall be repealed:
1. Decree No. 304/1998 Coll., laying down the cases in which
does not require an export permit for the export of excipients, details of
the registration of addictive substances, and precursors and on the documentation
substance abuse.
2. Decree No. 143/2000 Coll., amending Decree No. 304/1998 Coll.
laying down the cases in which does not require an export permit to export
excipients, details about the recording of addictive substances, preparations and
precursors and on the documentation of addictive substances.
3. Decree No. 82/2002 Coll., amending Decree No. 304/1998 Coll.
laying down the cases in which does not require an export permit to export
excipients, details about the recording of addictive substances, preparations and
precursors and on substance, documentation, as amended by Decree No.
143/2000 Sb.
4. Decree No. 363/2004 Coll., amending Decree No. 304/1998 Coll.
laying down the cases in which does not require an export permit to export
excipients, details about the recording of addictive substances, preparations and
precursors and on the documentation of addictive substances, as amended
regulations.
§ 17
The effectiveness of the
This Decree shall take effect on 1 January 2005. in May 2006, with the exception of the
the provisions of section 3 (3). 2, section 3, paragraph 3. 7 (b). m) and section 8 (2). 4 (b). I),
which shall take effect on 1 January 2005. January 1, 2007.
Minister:
Mudr. Rath v. r.
Selected provisions of the novel
Article. (II) Decree No. 72/2014 Sb.
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 for the service information
the company, in its up-to-date version.
1) § 2 (2). 1 of law No 378/2007 Coll., on pharmaceuticals and on changes and
addition of related laws (law on medicinal products), in the wording of the
amended.
§ 4 paragraph 2). 1 and section 13 (3). 2 (a). and point 1 of the law) No 378/2007 Coll., in
as amended.
section 4, paragraph 3). 2 of law No 378/2007 Coll., as amended.
4) section 6 (1). 1 (a). and Act No. 378)/2007 Coll., as amended
regulations.
5) section 6 (1). 1 (a). (b)) Law No 378/2007 Coll., as amended
regulations.
7) Act No. 563/1991 Coll., on accounting, as amended.
§ 5, paragraph 8). 6 (a). and) Decree No. 54/2008 Coll., on the way
the prescription of medicinal products, the information placed on the medical
Regulation and the rules of use of the medical regulations.
9) § 3 (3). 6 order No. 343/1997.
9) § 5 (3). 7 Decree No. 54/2008 Sb.
11) Law No. 101/2000 Coll., on protection of personal data and on amendments to certain
laws, as amended.
12) Government Regulation No. 463/2013 Coll., on lists of addictive substances.
13) section 34 of the Act No 272/2013 Coll., on drug precursors.
section 83, paragraph 14). 6 (a). (b)) Law No 378/2007 Coll., as amended
regulations.
