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This guidance is for sponsors of prescription medicines.
Our prescription medicine evaluators are organised into units based on the therapeutic indications of the medicines they evaluate. We have five prescription medicine clinical units (PMCUs).
Prescription medicine clinical unit 1
Analgesia
Neurological disorders
- migraine
- muscle relaxants
- insomnia
- disorders of the inner ear
Excludes:
Psychiatric/Psychological/Behavioural disorders
- addiction
- insomnia
- disorders of libido not due to hormonal deficiency
Excludes:
Anaesthesia
- general anaesthesia
- local anaesthesia
- muscle relaxants
Gastrointestinal disorders
- pancreatic exocrine enzyme deficiency
- vomiting
- combination products (antibiotic + anti-ulcer) for Helicobacter pylori
Excludes:
Poisoning
- Opioid antagonists
Nutrition
- Vitamins
- parenteral and enteral nutrition
Disorders of the mouth
- topical oral preparations
- dental products (including local anaesthetics for dentistry)
Excludes:
Disorders of the skin
- topical therapies
- topical anaesthetics for use on skin
- systemic therapies
Excludes:
Prescription medicine clinical unit 2
Infectious diseases
- antibacterials
- antivirals
- antirickettsials
- antifungals
- antiparasitics
- anthelmintics
- topical anti-infectives (e.g. skin, eye, ear)
Excludes:
Vaccination against infectious diseases
- Human papillomavirus vaccines (HPV) for prevention of cervical cancer
Immunological disorders
- immunosuppression following organ transplantation
- chronic fatigue syndrome
- systemic sclerosis
Excludes:
- autoimmune disorders are allocated according to body system
Other
- radiological agents (e.g. contrast media)
- adjuncts to radiopharmaceuticals and contrast media use
- diagnostic tests for infections
- allergens (diagnostic or therapeutic)
- antivenenes
- radiopharmaceuticals for cancer (diagnostic)
Prescription medicine clinical unit 3
Cardiac disorders
Lipid disorders
Inherited metabolic disorders
Vascular disorders
- cerebrovascular disease
- hypertension
- pulmonary Hypertension
- Deep Venous Thrombosis (DVT)/pulmonary embolus
- surgical haemostasis (non-plasma products)
Excludes:
Musculoskeletal disorders
- disorders of joints, muscle
- disorders of bone
- drug/device combinations for non-union of fractures
Excludes:
Disorders of the male reproductive system
- erectile dysfunction
- benign prostatic hypertrophy
Excludes:
Renal & urinary tract disorders
Excludes:
Disorders of the ear
- topical otic preparations
Excludes:
- topical otic anti-infective preparations (PMCU 2)
- disorders of the inner ear (e.g. Meniere's disease - PMCU 1)
Poisoning
- heavy metal poisoning
- cyanide poisoning
Excludes:
Prescription medicine clinical unit 4
Neoplastic disorders
Includes:
- solid tumour oncology
- hormonal effects of functioning carcinoid neoplasms
- radiopharmaceuticals for solid tumours (therapeutic)
Excludes:
- haematological malignancies (PMCU6)
- hormonal effects of other functioning neoplasms (e.g. pituitary, thyroid, adrenal - PMCU 5)
- HPV vaccines for prevention of cervical cancer (PMCU 2)
Prescription medicine clinical unit 5
Contraception
Infertility
Obesity
Osteoporosis
Paget's disease of bone
Endocrine disorders
- disorders of libido due to hormonal deficiency
Excludes:
- hormonal effects of functioning carcinoid neoplasms (PMCU 4)
- disorders of libido not due to hormonal deficiency (PMCU 1)
Disorders of the female reproductive system
- endometriosis
Pregnancy and labour
- post-partum haemorrhage
Fluid & electrolyte disorders
- hypovolaemia/shock
- dialysis solutions
Excludes:
Disorders of the eye
Excludes:
Respiratory disorders
Excludes:
Disorders of the nose, paranasal sinuses and upper airway
Excludes:
Prescription medicine clinical unit 6
Haematological disorders, including haematological malignancies
Includes:
- radiopharmaceuticals for haematological malignancies (therapeutic)
Other
- surgical haemostasis (plasma products)
Excludes:
Version history
| Version | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication Title: Guidance 4: Prescription medicine clinical units (PMCU) - previously ARGPM Appendix 4: Drug safety and evaluation branch clinical evaluation sections | Office of Medicines Authorisation | 12/07/2013 |
| V2.0 | Update to reflect change in clinical unit structure Title has been shortened. | Prescription Medicines Authorisation Branch with the Regulatory Guidance Team | April 2016 |
| V2.1 | Update to the six clinical evaluation streams and the functions each unit provides | Prescription Medicines Authorisation Branch | August 2017 |