1. ------IND- 2013 0604 CZ- EN------20131204 ------PROJET
Draft
DECREE
of ……2013,
establishing the format of the forms referred to in Act No 167/1998 Coll. on addictive substances and on amendments to certain other acts, as amended
In accordance with Section44b of Act No167/1998 Coll. on addictive substances and on amendments to certain other acts, as amended by Act No74/2006 Coll., Act No121/2009 Coll. and Act No273/2013 Coll. (hereinafter the “Act”), the Ministry of Health shall lay down:
Section1
Format of forms
(1)This decree shall establish the format of the forms for
a)the application for the issue of a permit to handle addictive substances and preparations, in accordance with Section8(6) of the Act and Section8(9) of the Act, in Annex1 to this Decree,
b)the application for modification of the permit to handle addictive substances and preparations, in accordance with Section9(10) of the Act, in Annex2 to this Decree,
c)the application for revocation of the permit to handle addictive substances and preparations, in accordance with Section8(11) of the Act, in Annex3 to this Decree,
d)the application for inclusion in the list of persons, with indication of their sites of work, whose activities do not require a permit to handle addictive substances and preparations containing these substances, in accordance with Section5(7) of the Act, in Annex4 to this Decree,
e)the application for modification of the particulars provided in the application for inclusion in the list of persons, with indication of their sites of work, whose activities do not require a permit to handle addictive substances and preparations containing these substances, in accordance with Section5(7) of the Act, in Annex5 to this Decree,
f)the notification of appointment of a deputy person in charge, in accordance with Section9(9) of the Act, in Annex6 to this Decree,
g)the application for the issue of a permit to import addictive substances and preparations, in accordance with Section22(2) of the Act, in Annex7 to this Decree,
h)the application for the issue of a permit to import poppy straw, in accordance with Section25(1) of the Act, in Annex8 to this Decree,
i)the estimate of imports of addictive substances and preparations, in accordance with Section26(1)(b) of the Act, in Annex9 to this Decree,
j)the application for the issue of a permit to export addictive substances and preparations, in accordance with Section22(2) of the Act, in Annex10 to this Decree,
k)the application for the issue of a permit to export poppy straw, in accordance with Section25(1) of the Act, in Annex11 to this Decree,
l)the estimate of production of addictive substances and preparations, in accordance with Section26(1)(b) of the Act, in Annex12 to this Decree,
m)the monthly report on actual imports of addictive substances and preparations, in accordance with Section26(1)(c) of the Act, in Annex13 to this Decree,
n)the monthly report on actual exports of addictive substances and preparations, in accordance with Section26(1)(c) of the Act, in Annex14 to this Decree,
o)the quarterly report on actual imports of poppy straw, in accordance with Section30 of the Act, in Annex15 to this Decree,
p)the quarterly report on actual exports of poppy straw, in accordance with Section30 of the Act, in Annex16 to this Decree,
q)the summary annual report on the production, consumption and disposal of, transactions in, and the stock levels and movements of addictive substances and preparations, in accordance with Section26(1)(a) of the Act, in Annex17 to this Decree,
r)AnnexI to the summary annual report on the production, consumption and disposal of, transactions in, and the stock levels and movements of addictive substances and preparations — supplies from domestic suppliers, in Annex18 to this Decree,
s)AnnexII to the summary annual report on the production, consumption and disposal of, transactions in, and the stock levels and movements of addictive substances and preparations — deliveries to domestic customers, in Annex19 to this Decree,
t)AnnexIII to the summary annual report on the production, consumption and disposal of, transactions in, and the stock levels and movements of addictive substances and preparations — details of production, in Annex20 to this Decree,
u)AnnexIV to the summary annual report on the production, consumption and disposal of, transactions in, and the stock levels and movements of addictive substances and preparations — intra-company transfers, in Annex21 to this Decree,
v)AnnexV to the summary annual report on the production, consumption and disposal of, transactions in, and the stock levels and movements of addictive substances and preparations – details of stock levels, in Annex22 to this Decree,
w)AnnexVI to the summary annual report on the production, consumption and disposal of, transactions in, and the stock levels and movements of addictive substances and preparations – disposal of waste and excess and unusable addictive substances and preparations, in Annex23 to this Decree,
x)the estimate of cultivation of cannabis for research purposes and for breeding of new varieties and conservation of genetic diversity, in accordance with Section26(1)(b) of the Act, in Annex24 to this Decree,
y)the summary annual report on cultivation of cannabis for research purposes and for breeding of new varieties and conservation of genetic diversity, in accordance with Section26(1)(a) of the Act, in Annex25 to this Decree,
z)AnnexI to the summary annual report on cultivation of cannabis for research purposes and for breeding of new varieties and conservation of genetic diversity — supplies from suppliers, in Annex26 to this Decree.
(2)This Decree shall also lay down the format of the forms for
a)AnnexII to the summary annual report on cultivation of cannabis for research purposes and for breeding of new varieties and conservation of genetic diversity — details of cultivation, in Annex27 to this Decree,
b)AnnexIII to the summary annual report on cultivation of cannabis for research purposes and for breeding of new varieties and conservation of genetic diversity — deliveries to customers, in Annex28 to this Decree,
c)AnnexIV to the summary annual report on cultivation of cannabis for research purposes and for breeding of new varieties and conservation of genetic diversity — details of processing, in Annex29 to this Decree,
d)AnnexIV to the summary annual report on cultivation of cannabis for research purposes and for breeding of new varieties and conservation of genetic diversity — details of disposal, in Annex30 to this Decree,
e)the report of the General Directorate of Customs on current and estimated areas sown with opium poppy and cannabis, in accordance with Section43(6)(a) of the Act, in Annex31 to this Decree,
f)the annual report of the General Directorate of Customs on the cultivation of opium poppy and cannabis, in accordance with Section43(6)(b) of the Act, in Annex32 to this Decree,
g)notification of consent from the regional administration office for the disposal of unusable medicines without the handling permit, in accordance with Section5(10) of the Act, in Annex33 to this Decree.
Section2
Entry into force
This decree shall enter into force on …………….. 2014.
Minister:
Annex1 to Decree No …/2013 Coll.
APPLICATION FOR THE ISSUE OF A PERMIT
to handle addictive substances and preparations
Number of pages of the application:Number of pages of attachments:
Revenue stamps (number and price) or variable symbol:
The applicant requests the issue of a permit to handle addictive substances and preparations
under Section8(6) of Act No167/1998 Coll.
under Section8(9) of Act No167/1998 Coll.: Lettersa), b) and c)
I.Applicant: / Application no *)Name:
(name of legal person / business name / first name and surname of natural person), including the distinguishing supplement
Address, including postal code:
(registered office of the legal person / place of residence of the natural person)
Postal address, including postal code:
if different from the address above
Identification no (IČO):
Telephone: / Fax: / Email:
______
*) If the administrative fee is paid by bank transfer, provide part of the variable symbol “XXX” as the application number, e.g. 078D
APPLICATION FOR THE ISSUE OF A PERMIT
to handle addictive substances and preparations
Identification no:The number of the relevant annex to Government RegulationNo …/2013Coll. / Name of the addictive substance or preparation (addictive substances and preparations in the following order:narcotic substances, psychotropic substances)
for addictive substances, provide the international nonproprietary name (INN) in Czech, in accordance with the annexes to the Government Regulation, including the names of the salts, isomers, esters and ethers, and their salts;
for PMP, provide only the registered names, including strength and package size;
manufacturers shall also specify the expected production quantity per calendar year (given in grams, millilitres or number of packages) / Abbreviation of the holder of registration of the relevant PMP /
Activity (choose from the list of activities):
-receipt-manufacture
-storage
-supply
-use
-research
-processing
-other / Specification of the activity (e.g. receipt-import, supply-export, cultivation, etc.) /
Address of the site where the activity will be performed
(specify the address, including postal code)
APPLICATION FOR THE ISSUE OF A PERMIT
to handle addictive substances and preparations
Identification No:III.The applicant requests the issue of a permit to handle addictive substances and preparations for the period of …… years (pursuant to Section8(3) of Act No167/1998 Coll., the maximum period is fiveyears)
IV.Natural persons authorised to act on behalf of the applicant:
(e.g. according to the Commercial Register)
First name, surname, title: / Telephone: / Position: / Signature:1.
2.
3.
4.
V.Person in charge
First name, surname, title: / Position: / Signature:Place of residence, including postal code:
Email: / Telephone: / Fax:
Stamp:Date:
______
Please cross out any unused boxes with a continuous line.
APPLICATION FOR THE ISSUE OF A PERMIT
to handle addictive substances and preparations
Identification No:Attachments to the application for the issue of a permit to handle addictive substances and preparations
The applicant shall attach the relevant attachments as an original, true copy or certified copy, unless otherwise specified below.
Attachment No / Attachments / Number of sheets / Attached to an earlier application for permit No1. / Documents to be provided by applicants not entered in the Commercial Register
(e.g. deed of establishment, including the letter of appointment of the statutory representative, certificate of assignment of the identification number).
2. / Extract from the Criminal Register (no older than threemonths) for all persons authorised to act on behalf of the applicant
(Section8a of Act No167/1998 Coll.) or provision of the necessary personal data for all persons authorised to act on behalf of the applicant (first name, surname, maiden name, personal number, place and district of birth)
3. / Contract - it is not required to provide the original, true copy or certified copy
(e.g. storage space lease agreement, contract on performance of professional veterinary services)
4. / The decision regarding authorisation for distribution in accordance with the Drugs Act,
the most recent version of the decision must always be provided
(Section13(2) of Act No378/2007 Coll.)
5. / The decision providing proof of authorisation for manufacturing in accordance with the Drugs Act,
the most recent version of the decision must always be provided
(Section13(2) of Act No378/2007 Coll.)
6. / Certificate of compliance with the requirements for the exercise of veterinary therapeutic and preventive activities
(Act No381/1991 Coll.)
7. / Production technical regulation - it is not required to provide the original, true copy or certified copy (Section8(6) of Act No167/1998 Coll.)
8. / Internal regulation or standard operating procedure for the handling of an addictive substance
9. / Applicant’s statement on safety measures taken
(Section8(6) of Act No167/1998 Coll.)
10. / Certificate of appointment of the person in charge
(Section8(5) of Act No167/1998 Coll.)
11. / Proof of qualifications of the person in charge
(Section9(3) and Section19(1) of Act No167/1998 Coll.)
12. / Extract from the Criminal Register (no older than threemonths) for the persons in charge or provision of the necessary personal data for the persons in charge: first name, surname, maiden name, personal number, place and district of birth)
(Section9(3) and Section17 of Act No167/1998 Coll.)
13. / Proof of medical fitness to perform the duties of a person in charge (no older than threemonths)
(Section9(4) and Section18 of Act No167/1998 Coll.)
14. / (Specify any other necessary attachments not mentioned above)
Page of the application
______
Attachments listed in bold must always be provided with an application submitted under Section8(9), the decisions must be provided only if they have been amended.
List of abbreviations:
INN - International Nonproprietary Name of a medicinal product
PMP - Proprietary Medicinal Products
APPOINTMENT OF A PERSON IN CHARGE
Legal person / natural person
Name:Address:
Identification No: / Stamp:
represented by:
First name and surname, title: / signature:First name and surname, title: / signature:
First name and surname, title: / signature:
First name and surname, title: / signature:
hereby appoints, in accordance with Section8(5) of Act No167/1998 Coll. on addictive substances
and on amendments to certain other acts, as the person in charge:
First name and surname, title:Date of birth:
Permanent address:
I accept this appointment as the person in charge:
In / on / signatureAnnex2 to Decree No …/2013 Coll.
APPLICATION FOR MODIFICATION OF THE PERMIT
to handle addictive substances and preparations
(change of the person in charge only)
Number of pages of the application:Number of pages of attachments:
The applicant requests modification of the permit to handle addictive substances and preparations No
in accordance with Section9(10) of Act No167/1998 Coll.
I.Applicant:
Name:(name of legal person / business name / first name and surname of natural person), including the distinguishing supplement
Address, including postal code:
(registered office of the legal person / place of residence of the natural person)
Postal address, including postal code:
if different from the address above
Identification No (IČO):
Telephone: / Fax: / Email:
II.Natural persons authorised to act on behalf of the applicant:(e.g. according to the Commercial Register)
First name, surname, title: / Telephone: / Position: / Signature:1.
2.
III.Newly appointed person in charge:
First name, surname, title: / Position: / Signature:Place of residence, including postal code:
Email: / Telephone: / Fax:
Stamp:Date:
______
Please cross out any unused boxes with a continuous line.
Page 1 of the application
Attachments to the application for modification of the handling permit
(change of the person in charge only)
Identification No:The applicant shall always attach the attachments below as an original, true copy or certified copy.
Attachmentno /Attachments
/Number of sheets
1. / Certificate of appointment of the person in charge.(Section8(5) of Act No167/1998 Coll.)
2. / Proof of qualifications of the person in charge.
(Section9(3) and Section19(1) of Act No167/1998 Coll.)
3. / Extract from the Criminal Register (no older than 3 months) for the persons in charge or provision of the necessary personal data for the persons in charge: first name, surname, maiden name, personal number, place and district of birth.
(in accordance with Section9(3) and Section17 of Act No167/1998 Coll.)
4. / Proof of medical fitness to perform the duties of a person in charge, no older than threemonths.
(Section9(4) and Section18 of Act No167/1998 Coll.)
5. / (Specify any other necessary attachments not mentioned above)
Page 2 of the application
APPOINTMENT OF A PERSON IN CHARGE
Legal person / natural person
Name:Address:
Identification No: / Stamp:
represented by:
First name and surname, title: / signature:First name and surname, title: / signature:
First name and surname, title: / signature:
First name and surname, title: / signature:
hereby appoints, in accordance with Section8(5) of Act No167/1998 Coll. on addictive substances
and on amendments to certain other acts, as the person in charge:
First name and surname, title:Date of birth:
Permanent address:
I accept this appointment as the person in charge:
In / on / signaturePage 3 of the application
Annex3 to Decree No …/2013 Coll.
APPLICATION FOR REVOCATION OF THE PERMIT
to handle addictive substances and preparations
In accordance with Section8(11) of Act No167/1998 Coll., the applicant requests the revocation of handling permit No
I.Applicant:
Name:(name of legal person / business name / first name and surname of natural person), including the distinguishing supplement
Address, including postal code:
(registered office of the legal person / place of residence of the natural person)
Identification No (IČO):
Telephone: / Fax: / Email:
II.Reason for and date of cessation of activities:(please specify in an attachment if space is not sufficient)
III.Documentation is kept at:
Name of legal person / business name / first name and surname of natural person:Registered office of the legal person / place of residence of the natural person, including postal code:
IV.Natural persons authorised to act on behalf of the applicant:(e.g. according to the Commercial Register)
First name, surname, title: / Telephone: / Position: / Signature:1.
2.
V.Person responsible for storage and availability of documents:
First name, surname, title: / Position: / Signature:Place of residence, including postal code:
Email: / Telephone: / Fax:
Stamp:Date:
______
Please cross out any unused boxes with a continuous line.
Page 1 of the application
Attachments to the application for revocation of a permit to handle addictive substances and preparations
Identification No:The applicant shall attach the relevant attachments as an original, true copy or certified copy.
Attachment No / Attachments / Number of sheets1. / Proposal for deletion from the Commercial Register with confirmation of receipt of the proposal by the court.
2. / Decision of the Trade Licensing Office to revoke the trade licence.
3. / Application of the business for revocation of the trade licence (with confirmation of receipt of the request by the Trade Licensing Office).
4. / Extraordinary notification (Section26(4) of Act No167/1998 Coll.) - within 30 days of cessation of activities.
5. / Protocol of transfer and receipt of documents and records for storage.
6. / (Specify any other necessary attachments not mentioned above)
Page 2 of the application
Annex4 to Decree No …/2013 Coll.
APPLICATION FOR INCLUSION IN THE LIST
of persons, with indication of their sites of work, whose activities do not require a permit to handle addictive substances and preparations
Number of pages of the application:Number of pages of attachments:
The applicant requests inclusion in the list of legal and natural persons, with indication of their sites of work, whose activities do not require a permit to handle addictive substances and preparations in accordance with Section5(7) of Act No167/1998 Coll.
I.Applicant:Name:
(name of legal person / business name / first name and surname of natural person), including the distinguishing supplement
Address, including postal code:
(registered office of the legal person / place of residence of the natural person)
Postal address, including postal code:
if different from the address above
Identification No (IČO):
Telephone: / Fax: / Email:
Page 1 of the application
APPLICATION FOR INCLUSION IN THE LIST
of legal and natural persons, with specification of their workplaces, for whose activities the permit to handle addictive substances and preparations is not required
Identification No:The number of the relevant annex to Government RegulationNo …/2013Coll. / Name of the addictive substance or preparation (addictive substances and preparations in the following order:narcotic substances, psychotropic substances)
for addictive substances, provide the international nonproprietary name (INN) in Czech, in accordance with the annexes to the Government Regulation, including the names of the salts, isomers, esters and ethers, and their salts;
for PMP, provide only the registered names, including strength and package size;
manufacturers shall also specify the expected production quantity per calendar year (given in grams, millilitres or number of packages) / Abbreviation of the holder of registration of the relevant PMP /
Activity (choose from the list of activities):
-receipt-manufacture
-storage
-supply
-use
-research
-processing
-other / Specification of the activity (e.g. receipt-import, supply-export, cultivation, etc.) /
Address of the site where the activity will be performed
(specify the address, including postal code)
APPLICATION FOR INCLUSION IN THE LIST