Licensing Flashcards
What are the 3 types of licences?
MA
ML
WDL
What are the 2 types of certificates?
CTC
CTX
Briefly outline the licensing process.
Clinical trials of px suffering disease.
Assembles data about drug properties (MA granted)
Plan to produce product in large batches, assemble and pack it for sale. (ML granted)
Plan to store and distribute product by wholesale (WDL granted)
Marketing and distribution
What is the key criteria in licensing a new medicine? (4)
Safety
Quality
Efficacy
Not cost
Define MA.
Formerly known as product licence.
What are the main features of MA?
MA holder = manufacturer
MA authorises the holder to: sell, support or export a medicinal product, procure its sale, supply, exploration and manufacture.
Import it or procure its importation.
Unlawful to supply or manufacture a medicine unless it has MA or exempted.
MA are issued for 5 years or less and may have restrictions.
After this period, MA holder must re-apply.
MHRA has the power to withdraw, amend and suspend a MA.
Information of the product must be sent to MHRA for it have an MA.
If it’s a new product, full information regarding its manufacture, testing (including clinical trails results) must be made available to the MHRA.
A SPC for the product must be submitted as part of the licensing process.
What are the main features of SmPC?
Describes the medicine’s properties and conditions attached to its use.
What is the definition of generic medicinal product? (3)
It has same qualitative and quantitative composition in active substances as the reference medicinal product and
It has the same form as the RMP
Bioequivalence with RMP has been evident.
What are the main features of generics?
Safety and efficacy data used from the RMP after data exclusivity period.
Data exclusivity period is 8 yers.
Patent protection period = 2 yrs.
What are the main features of biologics and biosimilars?
Biologic: Medicine made from natural sources.
Biosimilars: Biologic medicine likely an already licensed biologic medicines in terms of safety, quality and efficacy.
All biologics/biosimilars to be brand only.
ADR reported via yellow card scheme including brand name and batch number.
What are orpan drugs?
Drugs used to treat conditions that occur infrequently that the cost of developing and bringing a medicinal product to the market wouldn’t be recovered by the expected sales.
Define herbal medicines.
A medicinal product whose only active ingredients are herbal substances or herbal preparations.
What are the main features of herbal medicines?
Herbal medicines which are for sale to the public must have a licence. Licensed as a medicine or registered under the THR scheme.
N/A to Chinese medicine practitioners, herbalists compounding a medicine, herbal products marketed as foods.
What is the THR scheme for herbal medicines? (4)
Quality, safety and regulated manufacturing standards assured.
No data required for efficacy.
Must give px with PIL
THR logo (optional) and THR no (mandatory) on packaging.
What are the main features of Homeopathic medicines?
RPS doesn’t endorse homeopathy as a form of tx because of its weak evidence.
Stop Rx this type of medicine.
Explain the importance of pharmacovigilance.
Post-marketing surveillance of medicine safety.
Including black triangle medicines.
Completing yellow card to report ADR.
Reassessment +/-
May restrict drug use, dose, warnings , PIL in response to reports received. In severe cases, withdrawal of product’s MA.
Give e.g. of medicines that subject to additional monitoring. (1)
Black triangle
What is the criteria for black triangle medicines?
New active ingredient
Biological medicine
Given conditional approval.
Has been approved under exceptional circumstances.
Company that markets the medicine is required to carry out additional studies.
What are the main features of manufacturer’s licence?
Authorises the holder to manufacture or assemble a medicine unless exempted.
Manufacture doesn’t include dissolving, diluting or mixing used as a vehicle for administration.
Assemble: enclosing a product in a container which is labelled before the product is sold.
Licence describes premises, equipment, people and records and qualifications of people involved.
Manufacturer must comply with principles and guidelines for GMP.
MHRA inspectors visit to inspect premises and have powers to seize paperwork and take samples.
What are the main features of wholesale dealer’s licence?
Needed by any person who sells a medicinal product by way of wholesale dealing.
No person can sell a medicine by wholesale dealing unless they possess WDL.
Authorises holder to re-sell a medicine to anyone other than the end user.
Describes the premises where products are stored, distribution facilities, records and security.
Records required for medicines received and dispatched.
Licence holder must have an emergency plan for medicine recall.
MHRA visits to inspect premises.
MA holder doesn’t require WDK - sales made by manufacturer are excluded from definition of WDL.
When would it be appropriate for a pharmacist not requiring a licence? (7)
For anything done by or under the supervision in a registered pharmacy which consists of:
- Preparing or dispensing a medicine on a Rx.
- Preparing or dispensing medicines to a formula provided by the purchaser for administration to themselves or to someone in their care.
- Prepare or dispensing a medicine in the course of counter prescribing e.g. pharmacist has been asked by a patient to use their own judgement as to the tx required and px is present in the pharmacy at the time.
- Preparing stock of products for use in a, b and c.
- Preparing a stock of a medicine for sale from that pharmacy, provided the product isn’t advertised.
- Assembling a medicine product for retail sale without adverts from pharmacy or another other part of the same retail pharmacy.
- Wholesale dealing
Effect of these exemptions is to allow sale from a pharmacy of products without a MA that either the pharmacist makes themselves or procures the manufacture.
Regulations on packaging, labelling and PIL must be complied with before supplying a medicine to another person.
Explain how assembly is exempted from licensing.
No licence is required where medicinal product is manufactured or assembled by a doctor or dentist and supplied to a px in the tx course.
Same applies to assembly of medicines by a registered nurse or a registered midwife if the medicine is supplied to a px in tx course.
IN all cases above, medicine must bot be manufactured or assembled in a large scale or by an industrial process.
Explain how mixing is exempted from licensing.
Combining 2 or more medicine products together for the purposes of administering them to meet the needs of an individual.
Regulations affecting manufacturing of medicines don’t apply to the mixing of medicines by an appropriate practitioner if the mixing of medicines forms part of a CMP for px.
Regulations don’t applyy to person acting in accordance with Rx if the mixing or medicines form part of CMP for an individual.
State the difference between unlicensed product and unlicensed use.
Unlicensed product has no MA/SPC/BNF monograph.
Unlicensed use = medicine is licensed but the way it is used is not. Unlicensed use may or may not be listed or mentioned in BNF monograph for licensed product.
Explain the main features of unlicensed medicines.
Only Rx or dispensed if no equivalent licensed product exists.
Rx or dispensing an unlicensed medicine carries high risk and liability with prescriber and dispenser rather than manfacturer.
Pharmacist ensures that Rxer realise that the medicine that have been prescribed is unlicensed.
The pharmacist may wish to inform the prescriber about a suitable licensed alternative formulation (if ther’s one) or advise on a different (licensed) medicine if there is one.
Px informed that medicine is unlicensed and what this means.
All ADRs for unlicensed medicines reported via yellow card scheme.
All extemporaneous medicines are unlicensed .e.g OTC vitamin products.
Explain how specials is exempted from licensing.
Unlicensed medicines prepared by specials licence holder that are made on the doctor/dentist/nurse IP/ Pharmacist IP or SP for px use.
Manufacturer must hold a specials manufacturer’s licence, may not advertise or solicit orders for product, carry out manufacture under certain conditions to ensure product quality. Maintain written records.
Product may have a small market demand.
Dispensing pharmacy must keep records for 5 years, regarding px name, quantity of product, who manufactured it, batch number, date supplied to px.
Any ADR to specials reported via yellow card scheme.
What are the main features of unlicensed (off-label) use?
Prescribing of a licensed medicine being used outside of its licence.
Why may a medicine be used off label?
The licence indication doesn’t reflect established current knowledge or don’t include well proven uses of a drug.
Licensed indication vary between different brands or between brand and generic versions of the same medicine.
Unlicensed use may be due to dose, age (children), route and indication
Where can prescribers or pharmacist find information on unlicensed uses?
Px to be informed of unlicensed use.
Same issues apply to OTC use.
Unlicensed use due to indication can become an issue with medicines which have recently become available as generic.
Explain the main features of parallel imported medicines.
Medicines imported from another country which are versions of one already available in the UK that has UKMA.
Country must on approved country for imports list.
Product must have a MA from the country of manufacture.
Product must have no different effect from product covered by the UK MA.
Products needing a UKMA but instead of full MA with all data from clinical trials being submitted an application for a product licence (parallel import) - PL (PI) can be made instead.
Price of medicines vary
PI must be relabelled in English and must have a PIL in English inserted into the packaging.
What practical points do you need to consider for parallel imported medicines?
Check authenticity before dispensing.
Counterfeit medicines
Brand name different to UK version. If Rx is written generically then pharmacist can dispense either version but if written by UK brand name, same brand is dispensed.
Consider re-boxing the product if packaging includes lots of foreign language.
Watch out for:
- Calendar packs - relabelled in English days of the week.
- Expiry dates - different from UK version
- Pack size - different from UK version
Define counterfeit medicines.
Medicine deliberately and fraudulently mislabelled with respect to identity or source.
What are types of counterfeit medicines?
Illegally labelled authentic product
Relabelled expired product
Generic medicine packaged as branded medicine.
Sub-standard copy
Product containing no active or toxic ingredient.
Give e.g. of counterfeit medicines.
Lipitor (x3), Cialis, Zyprexa, Plavix, Ozempic
What steps do you need to take to prevent counterfeits?
Packaging
Better internet regulation
Supply chain security
Increasing public awareness
A UK system to detect counterfeits by scanning barcodes on the medicine’s packaging and compared this to a central data base of codes.
Give e.g. of medicines at risk of counterfeits. (4)
Lifestyle
High costs
High use
Markets where medicines are expensive
