Decree No. 307 / 2020 Coll.
Decree amending Decree No. 236 / 2015 Coll., laying down the conditions for the prescription, preparation, distribution, supply and use of individually prepared cannabis-containing medicinal products for therapeutic use
Valid
Order
Effective from 01.07.2020
Text versions:
01.07.2020
307
DECLARATION
of 23 June 2020
amending Decree No. 236 / 2015 Coll., laying down the conditions for the prescription, preparation, distribution, supply and use of individually prepared cannabis-containing medicinal products for therapeutic use
The Ministry of Health and the Ministry of Agriculture provides, pursuant to § 114 paragraphs 1 and 2 of Act No. 378 / 2007 Coll., on Medicines and on amendments to certain related laws (Act on Medicines), as amended by Act No. 50 / 2013 Coll., Act No. 70 / 2013 Coll., Act No. 66 / 2017 Coll., Act No. 44 / 2019 Coll. and Act No. 262 / 2019 Coll., to implement § 77 paragraph 1 (g), § 79 paragraph 2, § 79 paragraph 8 (a), § 79a paragraph 1 and 4 and § 80 of the Law on Medicines:
Decree No. 236 / 2015 Coll., laying down the conditions for the prescription, preparation, distribution, supply and use of individually prepared cannabis-containing medicinal products for therapeutic use, is amended as follows:
1. In Paragraph 1, the current text becomes paragraph 1 and the following paragraph 2 is added:
"(2) This decree further regulates the details, structure, form, manner and time interval of the provision of information on the results of treatment with individually prepared cannabis-containing medicinal products for therapeutic use. '
2. Article 3, including the title, reads:
Marking cannabis for therapeutic use
(1) Cannabis for therapeutic use intended for the preparation of an individually prepared medicinal product must be labelled on the packaging with the code set out in Annex 1 to this Regulation corresponding to the percentage of delta- 9-tetrahydrocannabinol and cannadiol indicated in the quality verification document referred to in Section 2 (3).
(2) For the labelling of an individually prepared cannabis-containing medicinal product for therapeutic use as provided for in Section 2, the Ordinance on the correct pharmaceutical praxi1 shall apply. '
3. Paragraph 4 (2), including footnote 2, reads as follows:
"(2) The prescriber must indicate on the electronic recipe, in addition to the general requirements laid down in the Decree on the Prescription of Medicinal Products (2), the dosage of the individually prepared cannabis-containing medicinal product for therapeutic use referred to in Section 2, the route of administration and the code of prescribed cannabis for therapeutic use listed in Annex 1 to this Decree.
2) Decree No. 329 / 2019 Coll., on the prescription of medicinal products for the provision of health services. '
4. In Article 4, the following paragraph 4 is added:
"(4) If the prescribing physician persists for the issue of an individually prepared cannabis-containing medicinal product for therapeutic use with an exact percentage of delta- 9-tetrahydrocannabinol and cannadiol, he shall note this in the electronic recipe. '
5. In Section 5, the word "Medicinal 'is replaced by the words" Preparation and dispensing'.
6. In Article 5, the current text becomes paragraph 1 and the following paragraphs 2 to 5 are added:
"(2) For the preparation of an individually prepared cannabis-containing medicinal product for therapeutic use, only cannabis for therapeutic use may be used, with a percentage of delta- 9-tetrahydrocannabinol of 0,3% or more and a maximum of 25,0% and a percentage of cannadiol of 23,0% or more.
(3) For the preparation and supply of an individually prepared cannabis-containing medicinal product for therapeutic use on the basis of an electronic recipe, only hemp for therapeutic use may be used, the actual percentage of which is delta- 9-tetrahydrocannabinol and cannadiol corresponding to the code set out in Annex 1 to this Decree, which is indicated by the prescribing physician on the electronic recipe.
(4) In case the prescriber makes an accurate percentage of delta- 9-tetrahydrocannabinol and cannadiol in the electronic recipe note, only an individually prepared cannabis-containing medicinal product for therapeutic use corresponding to the prescribed physician may be prepared for such an electronic recipe.
(5) In the event that the prescribing physician indicates in the electronic recipe note the exact percentage of delta- 9-tetrahydrocannabinol and cannadiol which does not correspond to the code provided for in Annex 1 to this Ordinance on the electronic recipe, the pharmacist shall not prepare the prescribed individually prepared cannabis-containing medicinal product for therapeutic use and notify the prescriber of this contradiction. '
7. The following Section 5a is inserted after Section 5:
Provision of information on treatment results
(1) A doctor prescribing an individually prepared cannabis-containing medicinal product for therapeutic use provides the Institute with information on the results of treatment of individual patients under Section 79a (4) of the Drug Act (hereinafter referred to as "the report") by 31 March at the latest, each calendar year.
(2) The report must contain information on the treatment of each individual patient:
(a) patients in the
1. the age group referred to in Annex 4 to this Decree,
2. the sex of the patient,
3. a numerical diagnosis of the underlying disease, leading to a health problem for which an individually prepared cannabis-containing medicinal product for therapeutic use has been prescribed, according to the International Statistical Classification List of Diseases and Associated Health Problems, and the duration of the underlying disease before treatment with an individually prepared cannabis-containing medicinal product for therapeutic use,
4. a numerical diagnosis of the health problem for which an individually prepared cannabis-containing medicinal product for therapeutic use has been prescribed according to the International Statistical Classification List of Diseases and Associated Health Problems,
5. Medicinal products taken at the same time as an individually prepared medicinal product containing cannabis for therapeutic use,
(b) prescribed by an individually prepared medicinal product containing cannabis for therapeutic use in the
1. the cannabis code for therapeutic use as set out in Annex 1 to this Decree,
2. the formulation of an individually prepared medicinal product containing cannabis for therapeutic use,
3. the prescribed total quantity of hemp for therapeutic use for each code referred to in Annex 1 thereto,
4. the duration of treatment with an individually prepared cannabis-containing medicinal product for therapeutic use,
(c) during treatment with an individually prepared cannabis-containing medicinal product for therapeutic use in the
1. information on adverse reactions that have occurred during treatment with the individually prepared cannabis-containing medicinal product for therapeutic use,
2. Evaluation of the outcome of treatment with an individually prepared cannabis-containing medicinal product for therapeutic use by the prescribing physician; and
3. the date of cessation of treatment with the individually prepared cannabis-containing medicinal product for therapeutic use, including justification.
(3) The report by the doctor shall be made available by means of an electronic form containing the particulars referred to in paragraph 2, which shall be published by the Institute on its website. ';
8. Annex 1 shall read as follows:
"Annex No 1 to Decree No. 236 / 2015 Coll.
Cannabis species for therapeutic use
| Kód | Druh konopí | Rozmezí THCa) | Rozmezí CBDb) |
|---|---|---|---|
| 9111000 | Cannabis sativa L | 25 % ≥ THC > 21 % | CBD < 1 % |
| 9112000 | Cannabis sativa L | 25 % ≥ THC > 21 % | 1 % ≤ CBD < 5 % |
| 9113000 | Cannabis sativa L | 25 % ≥ THC > 21 % | 5 % ≤ CBD < 7,5 % |
| 9114000 | Cannabis sativa L | 25 % ≥ THC > 21 % | 7,5 % ≤ CBD ≤ 23 % |
| 9121000 | Cannabis sativa L | 21 % ≥ THC > 18% | CBD < 1 % |
| 9122000 | Cannabis sativa L | 21 % ≥ THC > 18% | 1 % ≤ CBD < 5 % |
| 9123000 | Cannabis sativa L | 21 % ≥ THC > 18% | 5 % ≤ CBD < 7,5 % |
| 9124000 | Cannabis sativa L | 21 % ≥ THC > 18% | 7,5 % ≤ CBD ≤ 23 % |
| 9131000 | Cannabis sativa L | 18 % ≥ THC > 15% | CBD < 1 % |
| 9132000 | Cannabis sativa L | 18 % ≥ THC > 15% | 1 % ≤ CBD < 5 % |
| 9133000 | Cannabis sativa L | 18 % ≥ THC > 15% | 5 % ≤ CBD < 7,5 % |
| 9134000 | Cannabis sativa L | 18 % ≥ THC > 15% | 7,5 % ≤ CBD ≤ 23 % |
| 9141000 | Cannabis sativa L | 15 % ≥ THC > 12% | CBD < 1 % |
| 9142000 | Cannabis sativa L | 15 % ≥ THC > 12% | 1 % ≤ CBD < 5 % |
| 9143000 | Cannabis sativa L | 15 % ≥ THC > 12% | 5 % ≤ CBD < 7,5 % |
| 9144000 | Cannabis sativa L | 15 % ≥ THC > 12% | 7,5 % ≤ CBD ≤ 23 % |
| 9151000 | Cannabis sativa L | 12 % ≥ THC > 9 % | CBD < 1 % |
| 9152000 | Cannabis sativa L | 12 % ≥ THC > 9 % | 1 % ≤ CBD < 5 % |
| 9153000 | Cannabis sativa L | 12 % ≥ THC > 9 % | 5 % ≤ CBD < 7,5 % |
| 9154000 | Cannabis sativa L | 12 % ≥ THC > 9 % | 7,5 % ≤ CBD ≤ 23 % |
| 9161000 | Cannabis sativa L | 9 % ≥ THC > 7 % | CBD < 1 % |
| 9162000 | Cannabis sativa L | 9 % ≥ THC > 7 % | 1 % ≤ CBD < 5 % |
| 9163000 | Cannabis sativa L | 9 % ≥ THC > 7 % | 5 % ≤ CBD < 7,5 % |
| 9164000 | Cannabis sativa L | 9 % ≥ THC > 7 % | 7,5 % ≤ CBD ≤ 23 % |
| 9171000 | Cannabis sativa L | 7 % ≥ THC >4 % | CBD < 1 % |
| 9172000 | Cannabis sativa L | 7 % ≥ THC >4 % | 1 % ≤ CBD < 5 % |
| 9173000 | Cannabis sativa L | 7 % ≥ THC >4 % | 5 % ≤ CBD < 7,5 % |
| 9174000 | Cannabis sativa L | 7 % ≥ THC >4 % | 7,5 % ≤ CBD ≤ 23 % |
| 9181000 | Cannabis sativa L | THC 0,3 % ≤ 4 % | CBD < 1 % |
| 9182000 | Cannabis sativa L | THC 0,3 % ≤ 4 % | 1 % ≤ CBD < 5 % |
| 9183000 | Cannabis sativa L | THC 0,3 % ≤ 4 % | 5 % ≤ CBD < 7,5 % |
| 9184000 | Cannabis sativa L | THC 0,3 % ≤ 4 % | 7,5 % ≤ CBD ≤ 23 % |
| 9211000 | Cannabis indica L | 25 % ≥ THC > 21 % | CBD < 1 % |
| 9212000 | Cannabis indica L | 25 % ≥ THC > 21 % | 1 % ≤ CBD < 5 % |
| 9213000 | Cannabis indica L | 25 % ≥ THC > 21 % | 5 % ≤ CBD < 7,5 % |
| 9214000 | Cannabis indica L | 25 % ≥ THC > 21 % | 7,5 % ≤ CBD ≤ 23 % |
| 9221000 | Cannabis indica L | 21 % ≥ THC > 18 % | CBD < 1 % |
| 9222000 | Cannabis indica L | 21 % ≥ THC > 18 % | 1 % ≤ CBD < 5 % |
| 9223000 | Cannabis indica L | 21 % ≥ THC > 18 % | 5 % ≤ CBD < 7,5 % |
| 9224000 | Cannabis indica L | 21 % ≥ THC > 18 % | 7,5 % ≤ CBD ≤ 23 % |
| 9231000 | Cannabis indica L | 18 % ≥ THC > 15 % | CBD < 1 % |
| 9232000 | Cannabis indica L | 18 % ≥ THC > 15 % | 1 % ≤ CBD < 5 % |
| 9233000 | Cannabis indica L | 18 % ≥ THC > 15 % | 5 % ≤ CBD < 7,5 % |
| 9234000 | Cannabis indica L | 18 % ≥ THC > 15 % | 7,5 % ≤ CBD ≤ 23 % |
| 9241000 | Cannabis indica L | 15 % ≥ THC > 12 % | CBD < 1 % |
| 9242000 | Cannabis indica L | 15 % ≥ THC > 12 % | 1 % ≤ CBD < 5 % |
| 9243000 | Cannabis indica L | 15 % ≥ THC > 12 % | 5 % ≤ CBD < 7,5 % |
| 9244000 | Cannabis indica L | 15 % ≥ THC > 12 % | 7,5 % ≤ CBD ≤ 23 % |
| 9251000 | Cannabis indica L | 12 % ≥ THC > 9 % | CBD < 1 % |
| 9252000 | Cannabis indica L | 12 % ≥ THC > 9 % | 1 % ≤ CBD < 5 % |
| 9253000 | Cannabis indica L | 12 % ≥ THC > 9 % | 5 % ≤ CBD < 7,5 % |
| 9254000 | Cannabis indica L | 12 % ≥ THC > 9 % | 7,5 % ≤ CBD ≤ 23 % |
| 9261000 | Cannabis indica L | 9 % ≥ THC > 7 % | CBD < 1 % |
| 9262000 | Cannabis indica L | 9 % ≥ THC > 7 % | 1 % ≤ CBD < 5 % |
| 9263000 | Cannabis indica L | 9 % ≥ THC > 7 % | 5 % ≤ CBD < 7,5 % |
| 9264000 | Cannabis indica L | 9 % ≥ THC > 7 % | 7,5 ≤ CBD ≤ 23 |
| 9271000 | Cannabis indica L | 7 % ≥ THC > 4 % | CBD < 1 % |
| 9272000 | Cannabis indica L | 7 % ≥ THC > 4 % | 1 % ≤ CBD < 5 % |
| 9273000 | Cannabis indica L | 7 % ≥ THC > 4 % | 5 % ≤ CBD < 7,5 % |
| 9274000 | Cannabis indica L | 7 % ≥ THC > 4 % | 7 % ≥ THC > 4 % |
| 9281000 | Cannabis indica L | 0,3 % THC ≤ 4 % | CBD < 1 % |
| 9282000 | Cannabis indica L | 0,3 % THC ≤ 4 % | 1 % ≤ CBD < 5 % |
| 9283000 | Cannabis indica L | 0,3 % THC ≤ 4 % | 5 % ≤ CBD < 7,5 % |
| 9284000 | Cannabis indica L | 0,3 % THC ≤ 4 % | 7,5 % ≤ CBD ≤ 23 % |
(a) The percentage range of delta- 9-tetrahydrocannabinol for that code.
(b) The percentage range of cannadiol for the code. ';
9. In Annex No 2, the words "+ - 20% of the declared THC or CBD content 'shall be inserted after the words" Article 1'; the words "European Pharmacopoeia 'shall be replaced by the words" chromatography';
10. The following Annex 4 is added, including the title:
"Annex No 4 to Decree No. 236 / 2015 Coll.
Age groups of patients according to § 5a (2)
| Věkové skupiny |
|---|
| 18 až 35 let |
| 36 až 45 let |
| 46 až 55 let |
| 56 až 75 let |
| 76 až 85 let |
| 86 a více let |
This Decree was notified in accordance with Directive (EU) 2015 / 1535 of the European Parliament and of the Council of 9 September 2015 laying down a procedure for the provision of information in the field of technical and information society services.
Transitional provisions
1. In the case of the purchase of hemp for therapeutic use by the State Institute for Drug Control pursuant to Decree No. 236 / 2015 Coll., as effective before the date of entry into force of the Decree, such hemp for therapeutic use may be used until its expiry.
2. Cannabis for therapeutic use which has not been labelled on the packaging in accordance with Decree No. 236 / 2015 Coll., as effective from the date of entry into force of this Order, may be used only if the code referred to in Annex 1 to Decree No. 236 / 2015 Coll., as effective from the date of entry into force of the Decree, is given in a dossier which is supplied together with cannabis for therapeutic use to the person authorised to prepare medicinal products.
3. In preparation and dispensing of an individually prepared cannabis-containing medicinal product for therapeutic use prescribed for the electronic prescription issued before the date of entry into force of this decree, the procedure laid down in Decree No. 236 / 2015 Coll., as effective before the date of entry into force of this decree, shall be followed from the date of entry into force of this decree.
4. For the preparation and delivery of an individually prepared cannabis-containing medicinal product for therapeutic use on the basis of an electronic recipe issued prior to the date of entry into force of this Decree, cannabis may be used for therapeutic use labelled in accordance with Decree No. 236 / 2015 Coll., as effective from the date of entry into force of this Decree, provided that at such an electronic recipe the data on the content of delta- 9-tetrahydrocannabinol and cannadiol for therapeutic use used for preparation correspond to the above range of the appropriate code for delta- 9-tetrahydrocannabinol and cannadiol in Annex 1 to this Decree.
5. For the preparation and delivery of an individually prepared cannabis-containing medicinal product for therapeutic use on the basis of an electronic recipe issued after the date of entry into force of this decree, cannabis may be used for therapeutic use labelled in accordance with Decree No. 236 / 2015 Coll., as effective before the date of entry into force of this decree, provided that the indication of the content of delta- 9-tetrahydrocannabinol and cannadiol indicated on the packaging of cannabis for therapeutic use used for preparation corresponds to the range of the code for delta- 9-tetrahydrocannabinol and cannadiol according to the code given by the prescribing physician on the electronic recipe, if applicable.
6. The report pursuant to Section 5a of Decree No. 236 / 2015 Coll., as effective from the date of entry into force of this decree, submitted for the calendar year 2020, contains information on the results of treatment of individual patients in the period from the date of entry into force of this decree until 31 December 2020.
Efficacy
This Decision shall enter into force on 1 July 2020.
Minister for Health:
Mgr. et Mgr. Vojtěch, MHA, v. r.
Minister for Agriculture:
Ing. Toman, CSc., v. r.
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Regulation Information
| Citation | Decree No. 307 / 2020 Coll., amending Decree No. 236 / 2015 Coll., laying down the conditions for the prescription, preparation, distribution, supply and use of individually prepared cannabis-containing medicinal products for therapeutic use |
|---|---|
| Regulation Type | Order |
| Author | - |
| Collection | Code of Laws |
| Date of Promulgation | 01.07.2020 |
|---|---|
| Effective from | 01.07.2020 |
| Effective until | - |
| Status | Valid |
Legal Areas:
Administrative law
Health
The regulation text is for informational purposes only.
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