Medicinal products

Question 1

Medicinal products

Answer 1

• Restoring, correcting or modifying a physiological function by exerting a pharmacological, immunological or metabolic action
• Blood is not included

Question 2

Medicines and Healthcare products Regulatory Agency

Answer 2

Authority for medicenes in the UK

Question 3

Human Medicines Regulations 2012

Answer 3

• Medicenies cannot be sold if it does have a licence in the UK and HMR regulates this

Question 4

Revocation, variation or suspension

Answer 4

1) Harmful or ineffective - side effects
2) Incorrect information - on patient info leaflet
3) breach of licence
4) Unfullfilled licence
5) Information not provided
6) No longer EU based
7) Non complience for GMP
8) Public at risk
9) Poor manufacturing - After regulated unsafe production

Question 5

Orphan drugs

Answer 5

• Used less frequently due to rare conditions
  Requirements for Orphan drug
• Cost would not be recovered by sales
• disease thats life threatening and chronic illness
• no more than 5 in 10,000 patients
• Get 10 yrs of extra maketing

Question 6

Generics

Answer 6

• Same composition as RMPs and they have same pharmacutical form
• Cheaper than branded medicine
• Same bioequivalence so no difference to patient

Question 7

Abridged procedures

Answer 7

• Data exclusivity period 8 yrs for the formulation to cover for research and development
• Other companies can use the same formulation

Question 8

Early Access to Medicines Scheme

Answer 8

• Enables patients to have access to medicines which have not yet been authorised
• life-threatening or seriously debilitating conditions,
  no suitable alternative

Question 9

Pharmocovigilance

Answer 9

• New to market monnitoring of effects as not all of the groups of patients have been assessed so there could be side effects

Question 9

Yellow Card Scheme

Answer 9

• Saftey concerns or incidents due to medicines or medical devices
• Early wanning on products on saftey issues but some may not be reported