---
title: Licence Details
description: "Some drugs have restrictions on them according to the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations. Full definitions for each schedule are: If there is a restriction, the Controlled Dr"
---

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# Licence Details

### **Controlled Drug Category**

Some drugs have restrictions on them according to the Misuse of Drugs Act 1971 and the Misuse of Drugs Regulations.

- If your product has been categorised as a **controlled drug**, please click on the controlled drug schedule from the drop down list.
- If your drug is **not controlled**, click on No Controlled Drug Status.

Full definitions for each schedule are:

- **No Controlled Drug status**
- **Schedule 1 (CD lic)** – drugs with virtually no therapeutic use (e.g. LSD)
- **Schedule 2 (CD)** – Schedule 2 controlled drugs where full requirements apply (e.g. morphine, cocaine)
- **Schedule 2 (CD exempt safe custody)** – as for Schedule 2 (CD) but exempt from safe custody requirements (e.g. secobarbital)
- **Schedule 3 (CD no reg)** – Schedule 3 CD requirements apply but supply not required to be recorded in register
- **Schedule 3 (CD no reg, exempt safe custody)** - as for Schedule 3 (CD no reg) but exempt from safe custody requirements
- **Schedule 3 (CD no reg Phenobarbital)** - as for Schedule 3 (CD no reg, exempt safe custody) but exempt from handwriting requirements and emergency supply allowed for epilepsy
- **Schedule 3 (CD no reg Temazepam)** - as for Schedule 3 (CD no reg) but exempt from handwriting and prescription requirements
- **Schedule 4 (CD Anab)** – Schedule 4 drugs liable to misuse including most anabolic steroids and some growth hormones
- **Schedule 4 (CD Benz)** - Schedule 4, contains most benzodiazepines
- **Schedule 5 (CD Inv)** – Contains preparations of certain controlled drugs e.g. codeine which are exempt from full control when present in medicinal products of low strength

If there is a restriction, the Controlled Drug Category is listed on the SPC

 

 

### **Current Licensing Authority**

The Current Licensing Authority refers to the legal authority that has approved your product.

The following options are available:

- **None** – unlicensed drugs; lapsed, expired, or withdrawn licensed products; clinical trial drugs.
- **Medicines** **- MHRA** – currently available medicinal products having a valid product licence issued by MHRA or EMA.
- **Unknown** – where licensing information is unavailable for any reason. Unknown covers those products that have been discontinued by a manufacturer for commercial reasons and which may or may not have a valid product licence. Unknown is also used if it is not possible to allocate one of the other three terms.
- **Traditional Herbal Medicines** – MHRA – currently available traditional herbal medicines having a traditional herbal registration (THR) issued by the MHRA.

Please click your choice from the drop down list to highlight it.

 

 

### **Restrictions on Availability**

Please indicate if there are any restrictions on the availability of your product.

Click on the appropriate category from the drop down list to highlight it:

- **None** – no restrictions on product availability. This applies to the majority of prescribed products
- **Restricted Availability** – products that have restrictions on their prescribing and dispensing e.g. if a patient, prescriber and/or pharmacist must all be registered with a monitoring service
- **Individual Patient Supply** – a medicinal product that has been available, its licence may have been withdrawn or discontinued, but the product is still supplied by the manufacturer for specific clinical reasons to named patients
- **Imported** – a medicinal product that is not available in this country and has to be acquired from abroad usually by a specific importer e.g. IDIS
- **Clinical Trial** – a medicinal product undergoing a clinical trial. This could be a phase 2 or 3 clinical trial drug (that may or may not become a licensed product) or a drug imported for the trial and licensed elsewhere
- **Special** – products made under a specials manufacturing licence
- **Extemp** – extemporaneously prepared products made under the supervision of a Pharmacist against a prescription for a particular patient
- **Not Available** – medicinal products that have been withdrawn or discontinued by the company for commercial or safety reasons. These products are no longer available and cannot be acquired from the manufacturer on an ‘individual patient supply’ basis
- **For Patient Safety Consideration**

### **CHM Monitored**

Please highlight either yes or no to indicate whether this product has the black triangle status and so is on the CHM list.

If med data dm+d has auto-populated this field with Unspecified, this means that the information has not been provided previously.

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