Is CBD Legal in Czech Republic – updated August 2018

Is CBD Legal In Czech Republic

Is CBD Legal in Czech Republic

Je cbd olej legální v české republice? (kanabidiol)

Is CBD legal in Czech Republic? According to the 2015 declaration regarding medicinal products containing cannabis the Czech Republic law, states that THC in cannabis has a legal limit of 0.3%. This means that CBD is legal in the Czech republic as long as it contains less than 0.3% THC.

Medical Cannabis in the Czech Republic

In August 2013 Medical cannabis was legalised in the Czech Republic. The regulations contained certain restrictions, that limited patients to 180 grammes of dry matter per month.

Cannabis is not covered by Czech health insurance and very few doctors (currently only eight as well as 16 pharmacists) it’s illegal for anyone under 18 to receive a prescription.

Medical cannabis prescriptions must be obtained via a special electronic prescription. Patients must be diagnosed with a permitted illness –  multiple sclerosis, Parkinson’s disease, cancer & AIDS – and prescribed a cannabis prescription from a specific medical professional.

The Czech State Institute for Drug Control (SUKL) has taken applications for domestic growers, but in the past, rounds had chosen only one producer who grew just one strain with nearly 20 percent THC and very little CBD. The SUKL then refused to buy two of three pre-ordered batches of 23 pounds of dried cannabis from the sole supplier, a company called Elkoplast Slušovice, because of insufficient certification.

Hemp Regulations in the Czech Republic

Hemp is regulated as an industrial commodity and therefore has more relaxed limits on cultivation and processing than the neighbouring countries. As a result, Czech Republic is currently a world-leader in cannabis-infused products such as cosmetics and dietary supplements. Numerous Czech products on sale in the UK, Spain, Germany and many other European markets.

According to Czech Law, authorization for handling is not required for the collection, storage and processing of cannabis plants which may contain no more than 0.3% of tetrahydrocannabinol substances, and only cannabis for industrial, technical and horticultural purposes, as well as cannabis for these purposes.

Czech Republic -Is CBD Oil Legal in Czech Republic - CBDOilEurope.com

References:

https://www.loc.gov/law/help/decriminalization-of-narcotics/czechrepublic.php

https://www.leafly.com/news/politics/following-german-canadian-lead-czech-patients-push-cannabis-reform-court

https://www.prohibitionpartners.com/european-country-review/2017/8/23/what-does-the-future-hold-for-the-czech-cannabis-industry

https://www.legalizace.cz/en/

https://en.wikipedia.org/wiki/Cannabis_in_the_Czech_Republic

https://www.zakonyprolidi.cz/cs/2015-236

https://www.zakonyprolidi.cz/cs/1998-167

 

 

Conditions for prescribing, preparing, distributing, dispensing and using individually prepared medicinal products containing cannabis for therapeutic use

DECLARATION

of 4 September 2015

laying down the conditions for prescribing, preparing, distributing, dispensing and using individually prepared medicinal products for hemp containing hemp for therapeutic use

The Ministry of Health and the Ministry of Agriculture, in consultation with the Ministry of Defense, the Ministry of the Interior, the Ministry of Justice and the Ministry of Finance, pursuant to Section 114 of Act No. 378/2007 Coll., On Pharmaceuticals and on Amendments to Certain Related Acts (Act on Pharmaceuticals) 50/2013 Sb. and Act No. 70/2013 Coll., on the implementation of Section 77 (1) g), § 79 (2), § 79 para. (a), Section 79a (1) and Section 80 of the Pharmaceuticals Act:

  • 1

Subject of editing

This Decree regulates the rules of good distribution practice for cannabis for medical use and the conditions for prescribing, preparation, dispensing and use of an individually prepared medicinal product containing cannabis for therapeutic use.

  • 2

Cannabis species for therapeutic use and quantitative limitation

(1) For the prescription, preparation, dispensing and use of an individually prepared medicinal product containing cannabis for therapeutic use, only the cannabis types for medical use set out in Annex 1 to this Decree may be used up to a maximum of 180 g of dried herbal drug monthly.

(2) For the preparation of an individually prepared medicinal product, only cannabis for medical use according to paragraph 1 which meets the criteria set out in Annex 2 to this Decree may be used.

(3) The quality of cannabis for medicinal use in the preparation of medicinal products must be substantiated by the production of a document certifying the quality of a medicinal product issued in the European Union

(a) a manufacturer of medicinal products authorized to control active substances,

(b) a manufacturer of active substances holding a valid certificate of good manufacturing practice in the manufacture of active substances; or

(c) a laboratory meeting the GMP requirements laid down by the European Commission and the European Medicines Agency and meeting the requirements of good manufacturing practice shall be accompanied by a valid GMP or a control report issued by the inspectors of the competent authority of the Member State concerned; such a control report shall not be older than 3 years.

  • 3

Marking of cannabis for medical use

Cannabis for therapeutic use intended for the preparation of an individually prepared medicinal product must be marked on the packaging according to the characteristics listed in Annex 1 to this Decree. To designate an individually prepared medicinal product containing cannabis for therapeutic use in accordance with Section 2, the Decree on Good Pharmaceutical Practice 1 ) shall apply .

  • 4

Prescribing an individually prepared medicinal product containing cannabis for therapeutic use

(1) An individually prepared medicinal product containing cannabis for therapeutic use pursuant to Section 2 may, in the provision of health services, prescribe in the indications given in Annex 3 to this Decree only a physician with the specialized competence specified in this Annex, and only to patients who have achieved 18 years of age.

(2) The prescribing physician is obliged to prescribe in the recipe the general requirements stipulated in the decree on the prescription of medicinal products 2 ) , the dosage of the hemp-containing medicinal product prepared individually for therapeutic use according to § 2 and the route of administration. Next, the doctor is required to state the prescription

(a) a type of hemp for therapeutic use,

(b) the percentage of delta-9-tetrahydrocannabinol and

(c) percentage of cannabidiol content.

(3) The prepared medicinal product containing cannabis for therapeutic use according to § 2 may be prescribed for one recipe at a maximum amount corresponding to the dose to provide a one-month treatment for the given indication.

  • 5

Delivery of an individually prepared medicinal product containing cannabis for therapeutic use

An individually prepared medicinal product containing cannabis for therapeutic use may be issued only if it is prescribed for a valid electronic prescription containing the particulars pursuant to Section 4 (2).

  • 6

Final Provision

This Decree was notified in accordance with Directive 98/34 / EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services, as amended.

  • 7

Cancellation clause

Decree No. 221/2013 Coll. Laying down the conditions for the prescribing, preparation, dispensing and use of individually prepared medicinal products containing cannabis for medicinal use is abolished.

 

Criteria for hemp for therapeutic use

Parameter Method Limit
Identity
Macroscopic description Visual Whole or cut dried peaty inflorescences of dark green, gray-green to brown-green color composed in dense ears. Small flowers are covered with acorns, covered with glandular hairs on the upper side.
TLC a) ČL b) 2.2.27 visual evaluation
Tests for cleanliness
Foreign admixtures ČL 2.8.2 max. 2%
Loss of drying Article 2.2.32 max. 10.0%
Pesticide residues ARTICLE 2.8.13 Corresponding to the limits specified in Article 2.8.13
Heavy metals ČL 2.4.27 Pb – max 5.0 μg / g

Cd-max. 1.0 μg / g

Hg-max. 0.1 μg / g

Aflatoxins

– Aflatoxin B 1

ČL 2.8.18 max. 2 μg / kg
– Total aflatoxin content B 1 , B 2 , G 1and G 2 max. 4 μg / kg
Microbiological quality 5.1.4 ČT 2.6.12 a 2.6.13 max. 10 3 CFU e) / g
– TAMC c)

– TYMC d)

max. 10 2 CFU / g
Decomposition products

– cannabinol

HPLC f) – CL 2.2.29 max 1%
Content
– THC (DELTA-9-tetrahydrocannabinol)

– CBD (cannabidiol)

HPLC – clause 2.2.29 ± 20% of the declared THC or CBD content

Explanatory notes:

  1. a) Thin-layer chromatography.
  2. b) Czech Pharmacopoeia.
  3. c) Total number of aerobic micro-organisms.

(d) Total number of yeasts / molds.

  1. e) Colony forming unit (s)

(f) High performance liquid chromatography.

Annex No. 3 to Decree No. 236/2015 Coll.

Indications and specialized competence of the prescribing physician

Indication Specialized medical competence
chronic painless pain (especially pain associated with oncological disease, pain associated with degenerative disease of the locomotor system, systemic disease of the binder and immunopathological conditions, neuropathic pain, glaucoma pain) clinical oncology

radiation oncology

neurology

palliative medicine

treatment of pain

rheumatology

orthopedics

infectious medicine

internal Medicine

ophthalmology

dermatovenerology

geriatrics

spasticity associated with pain associated with multiple sclerosis or spinal cord injury, painless arrhythmic spasticity significantly limiting movement and mobility or breathing of the patient, involuntary neurological disease kinase and other medical complications originating in neurological disease or spinal cord injury with spinal cord injury, or brain injury, neurological tremor caused by Parkinson’s disease and other neurological disorders as determined by the attending physician neurology

geriatrics

nausea, vomiting, stimulation of appetite related to the treatment of cancer or to the treatment of HIV clinical oncology

radiation oncology

infectious medicine

dermatovenerology

geriatrics

Gilles de la Tourette syndrome psychiatry
surface treatment of dermatoses and mucosal lesions dermatovenerology

infectious medicine

geriatrics

Footnotes

1 ) Decree No. 84/2008 Coll., On Good Pharmaceutical Practice, Closer Conditions of Treatment of Medicines in Pharmacies, Medical Facilities and Other Operators and Facilities Issuing Medicinal Products, as amended by Decree No. 254/2013 Coll.

2 ) Decree No. 54/2008 Coll., On the method of prescribing medicinal products, the information provided on medical prescription and on the rules for the use of medical prescriptions, as amended.

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