The initiative must come from a company
The Danish medicines agency may only assess and possibly approve several cannabisbaserede drugs, if there are companies seeking to get some preparations are approvedThe Danish medicines agency may not ask the companies to apply for approval medicine. The Danish medicines agency has approved in a medicine with cannabis. The application came from the company GW Pharmaceuticals, who desired the approval of the medicinal product Sativex for the treatment of multiple sclerosis. The Danish medicines agency has not refused any applications for authorisation of medicinal products with cannabis, but we have notified several companies about the procedure. In short, there must first be someone who is applying to get their cannabisprodukt approved as a drug. It will say a company that has the authorization to produce medicinal products, the need to develop a cannabisprodukt and then seek to get the products approved for the Danish market. The company must submit the evidence of the medicine's effect and side effects as well as be able to demonstrate that the drug is being produced under approved conditions. The purpose of the approval procedures is to ensure that patients do not receive ineffective or dangerous drugs. The Danish medicines agency may only incorporate cannabis products in the pilot scheme, if there are companies who ask to get concrete products busy.
We process requests for footage of cannabis products, as soon as we get them in, and we record all the products, which companies and products meet the requirements.
The law on the pilot scheme of medical cannabis came into force on. January, and several companies have indicated that they are currently working on applications for new products. It is the Danish medicines agency expects that the ongoing will be added to more products in the pilot scheme. All the doctors have the ability to print the products, which are recorded in the trial on medical cannabis, but no doctor is obliged to do so. All the doctors can print magistrally manufactured medicines based on cannabis, but is not obliged to do so. In relation to applications for Marinol and Nabilone on the compassionate, so take the Danish medicines agency position to the doctors specific applications. January will be automatically calculated grants to medical cannabis in the pilot scheme, when it purchased after prescription at the pharmacy.
If a doctor prints Sativex, magistrally manufactured drugs with cannabis, or cannabisholdige medicinal products compassionate use (Marinol and Nabilone), the doctor can apply for enkelttilskud to the specific patient.
The Danish medicines agency may grant enkelttilskud for patients with diseases, where it can be convincingly that cannabisbaseret medicine works. As at other non marketed drugs are required in addition to all other treatment with approved drugs for the disease in question has been tried without sufficient effect. Applications are processed individually after the behandlingsvejledninger from relevant scientific societies. If you feel sleepy, lethargic, or dizzy, you should never drive a car, operate machinery or participate in hazardous activities. If a doctor prescribing THC-containing medication, the doctor must talk with the patient about trafikfarlighed, and in this context, your doctor may decide to impose a so-called driving ban. The Danish agency for Patient safety recommends currently to doctors, who prescribe treatment with the products included in the pilot scheme with medical cannabis, issue medical driving restrictions during the entire processing time. driving and cannabis treatment on the ministry of Patientsikkerheds website. Evidence does not belong in each of the countries. The results of scientific studies published in international journals in English and shared within scientific communities and between authorities across borders. Worldwide, there are not made very many scientific studies of high quality, which have investigated the effect or the side effects of cannabis in humans. So the evidence-based knowledge on the medical use of cannabis is very limited. This applies both in Denmark and abroad. The Danish medicines agency guidance for the pilot project on medical cannabis is among other things based on the international scientific literature on cannabis, as well as on the experiences from both the Netherlands, Canada and Israel. The cannabisolier sold on the web can have many different strengths and usually contains both THC and CBD. They are sold both as food, drugs and cosmetics.
The scheme is based on the initiative of private companies
That applies to the different legislation in the three areas. If there is talk about cannabisolie for medical use, the answer is no. Cannabisolie for medical use may only be sold in pharmacies and only to patients with a prescription from a doctor. For information about the rules for cannabisolier f. as dietary supplements or as cosmetics, we refer to respectively. The fda or the environmental protection Agency. It makes the Danish medicines agency. There is talk of an individual assessment of each product. If the oil contains active substances such as THC and CBD in a scale, which has an effect on the body, or if it is to be used for the treatment of disease, so it will probably be assessed as a medicinal product. If an oil is rated to be a medicinal product, it shall be approved or recorded in the pilot scheme in order that it can be sold at the pharmacy. July is considered cannabis products with a content of, two THC or less is no longer as regulated drugs. This means that it will be permitted to possess and distribute cannabis products with THC below the threshold. But by the side of this continues to apply rules on medicinal products, food supplements, food m.
v, which must be maintained.
It is difficult to answer, in general, of cannabis products on the net now are legal or not.
It depends on a concrete assessment the actual content, application, country of origin, production conditions m.
But in general, much of the cannabisolie sold on the net contain CBD in a quantity that affects the body. The oil will therefore probably be judged to be a drug, even if the THC content is below, two. If cannabisolien is a drug, it must either live up to the rules in the act or in the law on the pilot scheme with medical cannabis. Cannabisolie, which contains the CBD and sold on the web, therefore, is for the most part illegal - even if the oil contains less than, two THC, because it does not live up to the other rules that apply. First, one can not be sure of the content of the substances THC and CBD, when you buy products on the illicit market.
The strength may be too high and thus there may be a risk of serious side effects.
Secondly, even with the 'right' doses be side effects that require medical monitoring and possibly. Thirdly, there is no regulatory control of illegal drugs. Unfortunately, we have examples of illegal drugs are being made under unhygienic conditions and contain other than what it says on the label. It is dangerous in particular for sick people to ingest unknown substances, since neither the doctor or patient has the opportunity to anticipate, how the unknown substances will affect the disease and the other medication, you get. Ultimately you run the risk of becoming more ill. Children should under no circumstances be exposed to uncontrolled medicine. Specifically, in relation to the CBD is made research that has examined how the legally manufactured drugs with CBD affects children and young people with the rare epilepsisyndrom ”Dravet syndrome”.
The research showed that there might be a moderate positive effect on the number of seizures, but also showed serious side effects in the form of pronounced sleepiness, diarrhea, and elevated liver function tests, which may be signs of a toxic effect of the liver with a fifth of the children who received the CBD.
The Danish medicines agency does not recommend, therefore, strongly condemns the treatment of children with cannabisolie without medical supervision.
The Danish medicines agency is not aware that other EU countries in general would consider cannabisolier with the CBD to be a dietary supplement. Part countries just like Denmark, CBD is a substance.
It is possible that there are specific oils with a very low content of THC and CBD, which in certain countries have been classified as dietary supplements by the authorities in the specific country.
The Danish medicines agency's assessment is that the majority of the oils, as individuals introduces into disuse as cannabisolie, THC oil, or CBD oil most likely are not legal in the countries where they are sold from.
There must be a company who want to sell a specific cannabisolie as a dietary supplement.
Contains oil CBD, it must be evaluated by the Danish medicines agency to ensure that it does not contain as high a concentration of active substances that are assessed to be a drug. If the Danish medicines agency assesses that there is a drug, it can not be registered as a dietary supplement. If, however, there is not a drug, but a koststilskud is it the Fda who can then assess whether the oil conforms to the rules for dietary supplements. Legally speaking, it is not a criminal offence to buying illegal drugs for their own consumption. We enforce the rules for companies - not for the citizens who buy the products in the UK. You must, however, be aware that if you buy and possess CBD oils or other cannabis products, which may contain more than, two THC, it will also be a criminal offence to possess it. Illegal drugs may, however, be impure, wrong doses and wrong declared.
There is no security at the drugs purchased on the illicit market.
The Danish medicines agency advises therefore strongly recommended that you buy the illegal drugs.
Denmark has not approved any drugs with cannabis for horses, dogs, cats, or other animals. Animals are not within the scope of the pilot project on medical cannabis, and it is not possible to get the medication with cannabis to animals through the regulations, there is in the act ie. either on compassionate or as magistrally manufactured medicine.
There is therefore no legal possibilities in order to give medications with cannabis to animals.
It is not permitted itself to import medicines for animals, whether it is a legal or illegal product. Animals should not be exposed to illegal drugs. If you have a sick animal, he should talk with his veterinarian, who can advise on the appropriate treatment. Cannabis and synthetic cannabinoids is also on the list of prohibited substances in, for example, the equestrian.
