Medical Cannabis

Pursuant to Government Resolution 1587, which instituted a medicalization model for the cannabis plant, and as a result of the Israeli Ministry of Health reform and the establishment of the Medical Cannabis Unit, Dor established a Medical Cannabis Division with the objective of providing professional, high-quality solutions to Israeli medical cannabis companies that focus on shortening the time to market and on strict compliance with the new regulations. Dor’s customers include medical cannabis cultivation and propagation farms (indoor facilities and hothouses), medical cannabis production plants (oil extracts, cigarettes, packages of dried flowers, suppositories and a variety of additional forms of administration), medical cannabis storage and distribution stores, licensed medical cannabis pharmacies, importers of finished goods containing medical cannabis under EU-GMP, importers of food supplements, perfumes and foods containing medical cannabis (CBD, THC and more), manufacturers of medical devices that integrate medical cannabis, technology companies, entrepreneurs and start-up companies.

Dor Pharmaceutical Services Ltd. is a regulatory pioneer in the medical cannabis market in Israel. Dor’s expertise in the medical cannabis sector was demonstrated by its successful accompaniment of IMC-GMP audits under the new regulations pursuant to the directives of the Medical Cannabis Unit of the Pharmacy Department, the Ministry of Health. Over the years, Dor has instituted work processes and cooperative efforts with regulatory authorities in Israel and abroad in order to ensure that its customers receive the highest-quality service as quickly as possible.

Dor is a member of the Novolog Group. A number of medical cannabis companies operate within the Group, which supply logistics and distribution services to pharmacies, distribution to customers homes, logistics services to clinical research studies on medical cannabis and more.

Dor provides one-stop shopping services in the medical cannabis market, including: the establishment of facilities, validations, pharmacy services, product registrations, packaging materials and printing, qualifications, quality assurance and regulatory affairs, monitoring of adverse effects and clinical research.

Full involvement in the design and construction of medical cannabis production, rolling, extraction and packaging plants

Full involvement in obtaining IMC-GMP certification (good manufacturing practices for medical cannabis)

Involvement in the establishment of medical cannabis stores, performing summer and winter validations and certifications of the quality systems of medical cannabis stores under IMC-GDP

EU-GMP Post-Harvest

Regulatory advice in relation to EU-GMP post-harvest – assistance and involvement in the planning, construction, operation and qualification of growers and manufacturers in post-harvest sites, and in compliance with the regulatory requirements in Israel and abroad (IMC-GMP and EU-GMP)

Registrations of medical cannabis products

Registrations of medical cannabis products in Europe, registrations of medical cannabis products in countries that have legalized the sale of medical cannabis products, registrations with the regulatory authorities in Germany, the Czech Republic, Poland, Holland and more.

Packaging materials for medical cannabis products

End-to-End services, including patient leaflets and physician leaflets (SPC), labels and packaging materials for medical cannabis dried flowers, oils, rolls and more. Work opposite the regulatory authority, regulatory preparation and registration, translations to English and Hebrew, graphic design and layouts, proofreading, preparation for printing and full responsibility for printing at pharma grade printshops, which are supervised by the major pharmaceutical companies in Israel.

Drafting procedures for a medical cannabis cultivation standard – IMC-GAP

Regulatory assistance to private/white label medical cannabis companies

Assistance and supervision of shipments of raw materials from farms to local manufacturers, QP services for batch releases, QP pharmacist services for drugs, supervision of the interfaces between farms and manufacturing plants, training, quality agreements (SLAs) and assistance under the working conditions with medical cannabis during the transition between GAP (good agricultural practices) and GMP (good manufacturing practices)

Improving the quality assurance system for performing quality inspections at medical cannabis cultivation and propagation farms (indoor and hothouses)

Services of a quality assurance manager at medical cannabis production plants and batch releases by a certified QP

Services of a QP pharmacist for drugs at medical cannabis production plants

Dor assists medical cannabis production plants during their work and the construction stages up to inspections by the Medical Cannabis Unit, Pharmacy Department, Ministry of Health. QP service for drugs, including full regulatory assistance in managing the subject of drugs, the training of new pharmacists at production plants, managing the dangerous drugs manual, writing procedures specific to the topic of drugs.

Validation services for computerized systems at medical cannabis production plants, drafting of URS for all software, performing risk assessments, drafting of protocols, performing tests and producing final reports

Quality management for medical cannabis production plants, drafting work procedures for the plant and laboratory, drafting production methods, training plant employees, drafting quality agreements (SLAs) with suppliers and customers and more.

Certifying infrastructure, clean rooms and air-conditioning systems at medical cannabis production plants (including IQ/OQ/PQ)

Preparation of a product master file for medical cannabis production plants

Validation for machinery and equipment at medical cannabis production plants and trimming and drying houses (including IQ/OQ/PQ)

Validation services for cleaning at medical cannabis production plants, including the drafting of protocols and summary reports

Performing validation processes for dry products, wet products, rolled cigarettes and more

Monitoring of medical cannabis clinical research studies

Mapping of temperature and humidity at medical cannabis farms using external, independent measuring instruments in the local monitoring system

Drafting of site master files and validation master plans

Assistance with the importing and registration of imported cannabis products (soon)

Assistance with the importing and registration of food supplements, cosmetics and perfumes and foods containing medical cannabis (soon)

Permit-holder for importing medical cannabis products (soon)

Assistance in obtaining approval to import cannabis products for research and development purposes

Drafting of documents and submitting applications to the Helsinki Committee to conduct medical cannabis clinical research studies

Regulatory advice and assistance, regulatory opinions in Israel and abroad

Among our clients in the field of Medical Cannabis

Biobis Pharma