Act No. 50 / 2013 Coll.
Act amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Act on Medicines), as amended, Act No. 167 / 1998 Coll., on Addictive Substances and on Amendment to Certain Other Acts, as amended, and Act No. 634 / 2004 Coll., on Administrative Charges, as amended
Valid
Effective from 01.04.2013
50
THE LAW
of 30 January 2013
amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Law on Medicines), as amended, Act No. 167 / 1998 Coll., on addictive substances and amending certain other acts, as amended, and Act No. 634 / 2004 Coll., on administrative fees, as amended
Parliament has decided on this law of the Czech Republic:
Amendment to the Drug Act
Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Act on Medicines), as amended by Act No. 124 / 2008 Coll., Act No. 296 / 2008 Coll., Act No. 141 / 2009 Coll., Act No. 281 / 2009 Coll., Act No. 291 / 2009 Coll., Act No. 75 / 2011 Coll. and Act No. 375 / 2011 Coll., is amended as follows:
1. Paragraph 39 (3) to (7) reads as follows:
"(3) When deciding whether a medicinal product should be classified as a medicinal product subject to medical prescription only, the Institute shall assess whether the medicinal product:
(a) contains a substance classified as narcotic or psychotropic or precursor40) in quantities which do not permit dispensation without a prescription;
(b) may pose a significant risk of misuse of medicines, lead to addiction or be misused for illegal purposes, in incorrect use;
(c) contains a substance which, by virtue of being new or by virtue of its properties, may be considered as appropriate to the group as defined in point (b) under preventive measures.
(4) When classified in the category of dispensing medicinal products only under medical prescription, it may be provided by decision of the Institute that the medicinal product is to be issued only under restricted medical prescription. This may be prescribed only by a doctor with specialised competence or by a doctor with professional competence under the professional supervision of that doctor, on the basis of a written mandate issued by him. Where appropriate, a limitation may be provided for the quantity of medicinal product to be given to one patient within a specified period. When deciding on classification in this category, the Institute shall assess whether the medicinal product:
(a) for its pharmacological properties or because it is new, or in the interest of public health, it is reserved for treatment which can only be carried out in a bed care facility;
(b) is used to treat diseases that need to be diagnosed in bed care or in health care establishments with adequate diagnostic equipment, although administration and follow-up may not be carried out in such establishments;
(c) is intended for outpatient care patients, but its use may cause very serious adverse reactions or may pose a significant risk of abuse, requiring the issue of a prescription according to the requirements of a physician with specialised competence and special supervision during treatment.
(5) When classified as a medicinal product without a prescription, a decision of the Institute may provide that a medicinal product is to be issued with a restriction if it may give rise to a danger to human health which may be avoided by imposing certain restrictions on such dispensation or by the proper use of such a medicinal product, prior technical consultation with the pharmacist is necessary. Such medicinal product may only be issued to the person to whom it is intended, with the obligation of the authorised dispensing operator to keep documentation of its dispensation. Details of the professional assessment of the conditions for use of the medicinal product by the pharmacist and other restrictions may be laid down by the Institute in the Marketing Authorisation; In particular, the establishment of the age limit of a natural person requesting the supply of such a medicinal product, the determination of the dose for each administration, the limitation of the quantity of medicinal product to be given to one patient within the specified period shall be considered as such. The scope and manner of administration of the documentation on the dispensation of a medicinal product issued without a prescription with restriction shall be laid down in the implementing legislation.
(6) The Institute may waive the individual assessment of a medicinal product in accordance with the criteria set out in paragraphs 2 to 5, taking into account:
(a) the highest single dose, maximum daily dose, strength, pharmaceutical form, certain types of packaging; or
(b) other circumstances of its application.
(7) In the context of the renewal procedure, or where new facts are known to the Institute, the Institute shall, using the decision-making criteria referred to in paragraphs 2 to 5, review the classification for the dispensation of the medicinal product, taking into account that medicinal products with the same strength, the same package size and containing the same active substance are classified in the same product category. Where it is concluded that the procedure for issuing a marketing authorisation should be amended, it shall, in the event of an extension of the marketing authorisation, amend the procedure by a decision extending the validity of the marketing authorisation or initiate an own-initiative procedure. The Marketing Authorisation Holder shall submit draft amendments to the Summary of Product Characteristics, Package Leaflet and Labelling in these proceedings to the Institute. '
2. After Paragraph 79, the following Section 79a is inserted:
Individually prepared cannabis-containing medicinal products for therapeutic use
(1) For therapeutic purposes, an individually prepared cannabis-containing medicinal product for therapeutic use may be prescribed, issued and used in accordance with the implementing legislation which provides for:
(a) the types of medicinal hemp and the indications for which they may be used;
(b) the restriction on the issue of an individually prepared medicinal product containing cannabis for therapeutic use by quantities within a specified period (hereinafter referred to as the quantitative restriction);
(c) the specialist competence of a physician who may prescribe an individually prepared medicinal product containing medicinal cannabis for each diagnosis.
(2) For the purposes of the preparation of individually prepared cannabis-containing medicinal products for therapeutic use, the pharmacist shall be entitled to process the patient's personal data and the prescribing physician to the extent necessary to carry out the preparation or dispensing in accordance with paragraph 3.
(3) Before initiating the preparation of a medicinal product on the basis of an electronic prescription for a cannabis-containing medicinal product for therapeutic use, the pharmacist shall request the necessary data in the restricted medicinal product register provided for in Section 81a and shall process those data in order to determine whether the condition of the quantitative limit for preparation is met. The preparation shall not take place if a limited quantity of the medicinal product has already been issued to the patient within a specified period or if the restricted medicinal product register referred to in Section 81a contains a record of the preparation being made to achieve a quantitative restriction. If the conditions for preparation are met, the pharmacist shall immediately electronically report to the registry referred to in § 81a; the report shall contain the information referred to in § 81a (1) (a) and (b); the technical means of providing the data referred to in § 81a (1) (a) and (b) shall lay down the implementing legislation. ';
3. In § 80, the first sentence is added at the end of the text, "the prescription for a medicinal product limited in accordance with § 39 (4) (c) and the prescription for a medicinal product containing cannabis for therapeutic use is displayed exclusively in electronic form '.
4. In Section 80, the following is added at the end of the sentence of the second sentence: "; if the prescription for a medicinal product is limited in accordance with Section 39 (4) (c) and the prescription for a cannabis-containing medicinal product for therapeutic use, the central repository of electronic recipes shall communicate the identification mark only if the conditions for prescription are met '.
5. In Paragraph 81, the present text becomes paragraph 1 and the following paragraph 2 is added:
"(2) The central repository of electronic recipes shall be linked to the restricted medicinal product register referred to in Section 81a in order to ensure compliance with the restrictions laid down in the marketing authorisation provided for in Section 39 (4) (c) and with the implementing legislation for an individually prepared medicinal product containing cannabis for therapeutic use. ';
6. After Paragraph 81, the following Section 81a is inserted:
Register for restricted medicinal products
(1) A restricted medicinal product register is hereby established to ensure that the prescription and dispensation of the medicinal product are restricted to the quantities laid down in the marketing authorisation pursuant to Article 39 (4) (c) or Article 39 (5) and the restriction laid down in the implementing legislation for an individually prepared medicinal product containing cannabis for medical use ("restricted medicinal products'). Institute as administrator of the restricted medicinal product register
(a) process data on prescribed and issued medicinal products with restrictions;
(b) it processes personal data concerning the health care providers who have prescribed these medicinal products, the issuing pharmaceuticals and the patients to whom they have been prepared or issued, to the extent that the insured person's identification number is not the same as that of the insured person, the name, surname and date of birth of the natural person who has been issued the medicinal product, and the code of the medicinal product, which is assigned by the Institute, the quantity, the date of issue, the date of issue and the identification of the prescribing health care provider by indicating his number allocated by the health insurance undertaking, where the medicinal product is assigned by the issuing pharmacist, the number allocated by the Czech Chamber of pharmaceuticals and the operator authorised to issue;
(c) ensure free access to the data referred to in (a) and (b) relating to a patient to whom a restricted medicinal product is to be prescribed without charge to the prescriber immediately upon receipt of the doctor's request,
(d) ensure free of charge access to the data referred to in points (a) and (b) relating to a patient to whom such a medicinal product is to be prepared or issued with a restriction, immediately upon receipt of the application from the issuing pharmacist;
(e) process and store personal data on patients, prescribers of health services and dispensing pharmaceuticals after delivery only for the period for which the quantitative restriction of the medicinal product is provided for
1. in a marketing authorisation pursuant to § 39 (4) (c) or § 39 (5) for authorised medicinal products; or
2. in the implementing legislation referred to in Section 79a (1) for individually prepared medicinal products containing cannabis for therapeutic use; where no expenditure has been made, the period from the date of verification shall be calculated as to whether the conditions for preparation are met.
(2) The restricted medicinal product register is not publicly available. The prescribing physician and the issuing pharmacist shall have access to the personal data of the patient in the medicinal product register limited in order to verify whether, in relation to the patient to whom such medicinal product is to be prescribed, prepared or issued, the conditions of the restriction laid down in the marketing authorisation or in the implementing legislation are met. ';
7. Paragraph 83 (5) reads:
"(5) For the purposes of issuing medicinal products for medical prescription subject to the restriction of Paragraph 39 (4) or to medicinal products without the restriction of Paragraph 39 (5), the authorised person shall be entitled to process the personal data of the patient to the extent necessary to carry out the dispensation in accordance with the decision to register the medicinal product concerned. The issuing pharmacist shall, taking into account the nature of the restriction, request the necessary data in the restricted medicinal product register provided for in Section 81a and process those data in order to determine whether the conditions of the dispensation are met. The dispenser will not deliver if a limited quantity of the medicinal product has already been issued to the patient within the prescribed period, or if other conditions have not been met. In the event of the issue requiring verification of the conditions of the supply in the restricted medicinal product register pursuant to § 81a, the issuing pharmacist shall immediately submit an electronic notification to that registry; the report contains the information referred to in Section 81a (1) (b); the technical arrangements for the provision of those data shall be laid down in implementing legislation. ';
8. In Paragraph 83, the following paragraph 6 is added:
"(6) When dispensing individually prepared cannabis-containing medicinal products for medical use, the dispensing operator shall be entitled to process the personal data of the patient and the prescribing health service provider to confirm that the individually prepared medicinal product has been issued. ';
9. in Article 103 (10) (d):
"(d) issue a medicinal product without a prescription or an invalid prescription in contravention of § 82 (1), or issue a medicinal product which, according to the marketing authorisation, is issued without a prescription with a restriction in breach of § 39 (5) or issue a medicinal product which, under the marketing authorisation, is subject to a prescription with a restriction in breach of § 39 (4) or issue a medicinal product in breach of § 79a (1),"
10. in Article 108 (2), at the end of point (e), the dot is replaced by a comma and the following point (f) is added:
"(f) prescribe a medicinal product containing cannabis for therapeutic use in breach of Section 79a (1)."
11. in Article 108 (9) (b), the words "or (f)" shall be inserted after the words "paragraph 2 (b)."
12. in Article 114 (1), the words "Article 67 (10) and (11)" shall be inserted after the words "Article 79a (1)."
Amendment to the REC
Act No. 167 / 1998 Coll., on addictive substances and amending certain other laws, as amended by Act No. 354 / 1999 Coll., Act No. 117 / 2000 Coll., Act No. 132 / 2000 Coll., Act No. 57 / 2001 Coll., Act No. 185 / 2001 Coll., Act No. 407 / 2001 Coll., Act No. 320 / 2002 Coll., Act No. 223 / 2003 Coll., Act No. 141 / 2009 Coll., Act No. 167 / 2012 Coll., Act No. 228 / 2005 Coll., Act No. 74 / 2006 Coll., Act No. 106 / 2011 Coll., Act No. 341 / 2011 Coll., Act No. 375 / 2011 Coll., Act No. 141 / 2009 Coll., Act No. 167 / 2012 Coll., is amended as follows:
1. In Article 5 (5), the words "which may contain a maximum of 0,3% of the substances of the tetrahydrocaninol group, and only 'shall be inserted after the word" hemp'.
2. In Article 10 (3), the words "or cultivation 'shall be inserted after the words" production'.
3. In Paragraph 13 (1), at the end of the second sentence, the words "or solely for an electronic prescription, if the drug law so provides' shall be added.
4. In Article 15, the words "and thus without prejudice to the acquisition of such substances for therapeutic use or scientific purposes under the conditions laid down in this Act and the Law on medication6 'shall be added at the end of the text in point (f).
5. in Article 20 (2) (e), the words "which may contain a maximum of 0,3% of the substances of the tetrahydrocannabinol group," shall be inserted after the words "hemp."
6. In Article 21 (2) (d), the words "which may contain a maximum of 0,3% of the substances of the tetrahydrocaninol group," shall be inserted after the words "hemp."
7. In Section 24, the words "except for cultivation on the basis of a licence granted under this Act 'shall be added at the end of point (a).
8. The following Sections 24a and 24b are inserted after Section 24, including footnotes 14 to 16:
(1) Only legal or business natural persons licensed for this activity by the State Institute for Drug Control can grow hemp for medical use. The licence holder may only start growing cannabis for therapeutic use if authorisation is granted for the treatment of addictive substances and preparations.
(2) In order to grant the licence, the State Institute for the Control of Medicinal Products carries out a selection procedure under another legislation14). The selection procedure shall be held as two-wheel drive. For the first round, qualification assumptions, procurement documents and technical conditions, including the rules of good cultivation practice, shall be laid down for which the tenderer shall proceed to the second round. The transferee may be the only person who can demonstrate the preconditions to ensure that hemp is grown in accordance with a standardised procedure leading to the defined content of the active ingredients of hemp and the constant quality of the hemp produced. In the second round of the tendering procedure, the basic assessment criterion shall be the price offered for hemp grown, the weight of which must be at least 75% in relation to the partial evaluation criteria when determining the tender conditions. The maximum number of persons to whom a licence may be granted may be limited in the terms of the specifications. The State Institute for Drug Control shall not grant a licence to any of the tenderers if the price offered, plus the estimated costs referred to in § 24b (2) last sentence, exceeds the price of cannabis for therapeutic use available from other countries; for the purpose of market research, the State Institute for Drug Control before the second round of the selection procedure shall carry out demand in countries which may export hemp for therapeutic use, the parameters of which shall correspond to the selection procedure in terms of quantity of cannabis and content of active substances.
(3) Licences are granted for a maximum period of 5 years following the selection procedure. The licence of the State Institute for Drug Control defines the area on which cannabis will be grown. If the period of validity of the licence is to expire or if the hemp grown for medical use is insufficient, a new selection procedure shall be launched and the licence may be granted again and again.
(4) The person who has been granted a licence to grow hemp for medical use is obliged to:
(a) ensure that cultivation and processing are carried out in sheltered areas suitable for this purpose;
(b) to secure premises where cultivation, harvesting and processing are carried out before abuse;
(c) ensure that any activity relating to cultivation, harvesting and processing is registered;
(d) at any time, allow the State Institute for Drug Control to carry out checks without prior notification on all areas used for cultivation and processing and make available to it activity reports and other relevant documentation; Other legislation (15) applies mutatis mutandis to the rights and obligations of control and control persons;
(e) ensure that all plant waste is kept in the manner set out in Section 10 and disposed of for its own cargo in accordance with Section 14; hemp which does not comply with the specifications and technical conditions laid down in accordance with paragraph 2 shall also be considered as plant waste,
(f) comply with the conditions laid down in paragraph 2.
(5) Where the State Institute for Drug Control finds an infringement imposed pursuant to paragraph 4 to a person who has been granted a licence to grow hemp for medical use, it shall withdraw the licence.
(1) Cannabis grown and harvested in accordance with the conditions laid down in Article 24a (2) shall be transferred exclusively to the State Institute for Drug Control. This transfer shall be accompanied by a quality certificate issued by the control laboratory, the activity of which is authorised under the Drug Act (6). The State Institute for Drug Control shall redeem the hemp harvested no later than 4 months after its harvest. The transfer shall be subject to a written contract of purchase, the details of which include the precise specification of the hemp harvested for therapeutic use, the quantity, the quality and the determination of the purchase price, which shall not exceed the price offered in the second round of the tendering procedure and shall correspond to the extent to which the technical conditions of the selection procedure referred to in Article 24a (2) have been met. Cannabis is passed by protocol.
(2) During the transport of the hemp harvested, it must be ensured that the delivery is not misused in any way and is delivered exclusively to the pharmacy operator for the preparation of medicinal products. A written purchase contract shall be concluded between the State Institute for Drug Control and the pharmacy operator for the transfer of hemp, for which the provisions of paragraph 1 shall apply mutatis mutandis, and hemp shall also be transmitted in a protocol. The purchase price for the transfer of hemp to a pharmacy operator is the price subject to the price adjustment in kind under another legislation16). Its basis is the purchase price at which cannabis was purchased from the person licensed. The purchase price for the transfer of hemp to a pharmacy operator shall be non-profit-making, increased by the cost of taking over the hemp from the licensed person, ensuring the transport and protection of cannabis from abuse during such transport, the cost of storage and the cost of handing over to the pharmacy operator.
14) Act No. 137 / 2006 Coll., on Public Procurement, as amended.
15) Act No. 552 / 1991 Coll., on State Control, as amended.
16) Act No. 526 / 1990 Coll., on Prices, as amended. '
9. in Article 26 (1) (a), the word "cultivation" shall be inserted after the word "production."
10. in Article 26 (1) (b), the word "cultivation" shall be inserted after the words "April production estimate."
11. in Paragraph 34 (1), the words "and treatment of cannabis for therapeutic use" shall be added at the end of the text of point (d).
12. in Article 36 (1) (g), the words "or cultivation" shall be inserted after the words "production."
13. in Article 36 (1), the words "except for the cultivation of hemp for the medicinal use for which it is licensed" shall be added at the end of the text in point (t).
14. In Article 36, the following paragraph 8 is added:
"(8) A natural person who is a legal or legal person commits an administrative offence by infringing an obligation under § 24a (4) (a), (b), (c), (d), (e) or (f) or § 24b (1) as a person who has been granted a licence for the cultivation of hemp for medical use. '
15. In Paragraph 37, the following paragraph 8 is added:
"(8) For an administrative offence pursuant to § 36 (8), a fine of up to CZK 1 000 000 shall be imposed."
16. In Paragraph 38 (1) of the Introductory Part of the provision, the words "or cultivation 'shall be inserted after the word" production'.
17. In Paragraph 43, the following paragraph 8 is added:
"(8) State Institute for Drug Control
(a) carry out the tasks of the State Agency for Cannabis for medicinal uses2a);
b) keep the Ministry of Health and Police of the Czech Republic informed about
1. measures taken to ensure the cultivation and processing of hemp for therapeutic use;
2. licences granted for the cultivation of hemp for medical use,
3. infringement of obligations under this Act and of decisions given under it,
(c) comply with the notification obligation to the Ministry of Health pursuant to § 43a (4) (f). ';
18. in Paragraph 43a (1) (c) (2), the word "cultivation" shall be inserted after the word "production."
19. in Paragraph 43a, at the end of paragraph 2, the dot is replaced by a comma and the following point (c) is added:
"(c) be entitled at any time by remote means through a designated contact point in the event of the detection of cannabis or cannabis-containing product by a person to make a request against a restricted medicinal product registry under the Medicines Act (6), whether that person is kept between persons who have been issued an individually prepared cannabis medicinal product for therapeutic use; The registry shall comply with such a requirement without delay and shall communicate the required information without charge. Where the person is kept among persons who have been issued an individually prepared medicinal product containing cannabis for medical purposes, he shall also communicate the date of issue and the total quantity of the medicinal product individually prepared for therapeutic use. ';
20. in Paragraph 43a, the following paragraph 4 is added:
"(4) State Institute for Drug Control
(a) grant licences for the cultivation of hemp for medical use; the licence shall contain an indication of the area, the parcel number, the name of the cadastral territory, the name of the registered variety used and the soil block identification number and, where applicable, the soil block part according to land use records,
(b) checks the compliance of cannabis cultivation for medical use with the conditions laid down in Article 24a (2) and the compliance of the processing and storage of cannabis for therapeutic use with the rules of good manufacturing practice and controls its security against theft and abuse in the framework of public health protection;
(c) purchase all the crops produced and harvested of hemp for therapeutic use, the quality of which is certified in accordance with Article 24b (1), not later than 4 months after its harvest;
(d) export hemp for medical use under the conditions laid down in this Law;
(e) ensure the safe storage, transport and distribution of cannabis for medical use, including through other persons under contract;
(f) notify the Ministry of Health in writing or in electronic form signed by a guaranteed electronic signature under another legislation10a)
1. by the end of February, for the previous calendar year, an annual declaration of the quantities of hemp produced, processed, disposed of, accepted, issued for therapeutic use, including exports, trade, status and movements of its stocks,
2. by the end of April, an estimate of cannabis production for therapeutic use for the following calendar year; that estimate may be adjusted 10b) by the International Narcotics Control Office 2a),
3. by the 15th day of the following calendar month, monthly reports of cannabis exports for medical use for the preceding calendar month. ';
21. In Annex 1, the words "Cannabis extract and tincture 'are inserted after the words" Cannabis for therapeutic use or scientific purposes'.
Amendment of the Administrative Charges Act
Act No 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 13 / 2011, Act No. 13 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No. 31 / 2011, Act No 2011, Act No 2011, Act No. 13 / 2011, Act No 2011, Act No. 2011, Act No. 31 / 2011, Act No. 2011, Act No. 13, Act No 2011, Act No 2011, Act No 2011, Act No 2011, Act No 2011, No 2011, No 2011, Act No 2011, Act No. 2011, Act No. 2011, No 2011, Act No. 2011, No 2011, Act No No. 2011, No 2011, No 2011, Act No. 2011, No 2011, Act No 2011,
"Heading 99A
| Vydání licence k pěstování konopí pro léčebné použití76) | Kč 2 000 |
76) § 24a of Act No. 167 / 1998 Coll., as amended by Act No. 50 / 2013 Coll. '
EFFECTIVE
That law shall take effect on the first day of the calendar month following its publication, with the exception of the provisions of points 2, 7 to 18 and 20 of Part Two of Article II, which shall take effect on the first day of the twelfth calendar month following its publication.
Germany
Klaus v. r.
Nausea v. r.
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Regulation Information
| Citation | Act No. 50 / 2013 Coll., amending Act No. 378 / 2007 Coll., on Medicines and on Amendments to Certain Related Acts (Act on Medicines), as amended, Act No. 167 / 1998 Coll., on Addictive Substances and on Amendments to Certain Other Acts, as amended, and Act No. 634 / 2004 Coll., on Administrative Charges, as amended |
|---|---|
| Regulation Type | - |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 04.03.2013 |
|---|---|
| Effective from | 01.04.2013 |
| Effective until | - |
| Status | Valid |
The regulation text is for informational purposes only.
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