Legislation 2 - HMR - Licensing Flashcards
what is marketing authorisation (MA) needed for?
every MP - before being prescribed/sold
what is the job of licensing bodies in MAs? (4)
- functions carried out by MHRA
- submitted by pharmaceutical industry (anyone can submit a request)
- 210 days to go through process
- 30 days to inform approval granted
what is the manufacturing and wholesale dealing (Part III)? (3)
- sets out rules for manufacturing, importing and wholesale dealing
- establishes what the licensing authority must consider when assessing application
- sets out requirements for responsible persons and qualified person
what is the manufacturer’s/whole sale dealer’s license like? (3)
- granted by licensing authority (90 days)
- remains in force until surrendered/revoked
- may be suspend/revoke/vary with 28 days notice/immediate suspension (max 3 months + further 3 months)
what is the manufacturer’s license?
MP manufactured in the UK must be produced on a site that hold an appropriate ML
what is the wholesale dealer’s license?
company/individual wishing to wholesale deal MPs within the EU must hold WDL
how is the WDL used? Eg/ (2)
clinical trial authorisation
- needed by new products under development
- needed before being tested on humans
what can a person not do without a ML? (2)
- manufacture, assemble or import from a state other than EEA state any MP
- posses a MP for any of the above purposes
who is MA issued by?
competent authority (MHRA)
when is a ML not needed? what does it not apply to?
- person who imports MP for personal use
- mixing of medicines
what does manufacture include in ML?
any process carried out in the course of making a MP (+packaging and labelling, assembly of the final product)
what are the considerations of the ML? (3)
- MP manufactured must have a MA
- MA must be held by manufacturer who is making/ordering the making of the product
- QP needed to oversee process
who is the site inspected by in ML?
MHRA inspectorate to ensure criteria and standards are met at least every 2 yrs
what are the criteria and standards for ML? (3)
- appropriate facilities, equipment and suitably trained staff available and maintained
- all products made to standards detailed by EC guide to good manufacturing practice (GMP)
- quality assurance measures are built into each step - ensures safety, quality and efficacy of the product
what is distributing by way of wholesale dealing a reference to? (2)
- selling/supplying it
- procuring/holding/exporting to another EEA state for the purpose of sale/supply
what is the WDL to a person who receives it for a purpose of? (2)
- selling/supplying the product
- administering it/causing it to be administered to one ore more human beings
what does wholesale dealing cover?
sale of a MP to a person who buys the product for the purpose of sale/supply to someone else
(includes sale of a MP to a medical practitioner for use in their practice)
what does wholesale dealing exclude? (3)
- pharmacy supplying to a patient
- supply by one hospital to another (same trust)
- supply by a hospital pharmacy to a ward for administration to a patient
what is the licensing primarily concerned with in a WDL? (5)
- id of the distributor
- suitability of the premises used for storage. distribution, stock control
- inspected before WDL at least once during 5yr period of license
- GSL
- RP needed to oversee process
when is a WDL not needed? (4)
- takes place on occasional basis
- quantity of medicines supplied is small
- supply is made on a not for profit basis
- supply is not for onward wholesale distribution
what are the steps in product development? (5)
- NCE
- clinical trials
- MA
- production (ML)
- distribution to patients (WDL)
what are the parts of the development process? (6)
- discovery: 5000 to 10000 molecules
- preclinical testing: 250
- phase I: 5
- phase II: 2-3
- phase III: 1-2
- phase IV (registration approval 1 molecule)
what are the phases in clinical trials? (3)
- phase I: healthy people to find out how the med works in the body
- phase II: how the drug works in a particular condition
- phase III: how well the med works and how safe it is in the general population
what are the steps in the clinical trials application? (7)
- introduced May 2004
- emphasis on controlling the product to authorisation of the trial
- approval by MHRA 60 days
- regulation of healthy volunteer trials
- inspections for GPC and GMP
- labelling requirements
- ethics committee system
what does the evaluation of safety and efficacy look at? (7)
- nature of API
- dosage form
- nature of disease/condition treated
- type of patient
- duration of treatment
- more effective than placebo
- risk to benefit ratio
what does the evaluation of quality look at?
product’s physical, pharmaceutical and biological characteristics
= to ensure that each batch of the medicine is capable of performing reliably and consistently
what are the parts in granting of MA? (4)
- submission of necessary documentation (fees)
- validation (completed forms)
- assessment (sufficient info to evaluate safety, quality and efficacy, CHM/EAG licence/refusal)
- applicant has right of appeal
what is considered when granting a MA? (6)
- benefits vs risks?
- dosage form?
- nature of disease?
- dose?
- patients? (age,sex)
- side-effects?
what is not considered when granting a MA? (3)
- is there a need for the MP?
- comparison with others?
- price?
what are the requirements for authorisation (part IV)? (3)
- subject to appropriate license (MA, homeopathic cert of reg, traditional herbal reg, article 126a authorisation)
- illegal to sell/supply/offer to, an authorised MP
- offences lead to fines/imprisonment
what does a UK MA authorise the holder to do? (4)
- sell, supply or export the MP
- procure sale, supply or export of the MP
- procure manufacture/assembly of the MP for sale, supply or export
- import the MP
who does the holder of the MA have to be? (2)
- manufacturer
- person to whose order the product is made
what is the MA like? (4)
- valid for 5 years initially (renewal - unlimited unless safety concerns, up to date data supplied)
- new meds usually POMs
- on market within 3 yrs
- pharmacovigilance (black triangles, yellow card)
what are the systems used to register meds in europe? (4)
- centralised
- decentralised
- mutual recognition
- national
what is the centralised system for registration like? (3)
- single application to EMA
- single european authorisation granted
- certain meds only licensed this way to ensure automatically available to every EU member state
what are examples of certain meds that are registered by centralised system? (3)
- gene therapies
- meds for HIV/AIDS, cancer, diabetes, Altzheimer’s
- orphan drugs (meds for rare diseases)
what is the decentralised system for registration like? (2)
- same application submitted simultaneously in number of member states (one state takes lead)
- identical national licenses issued in each state involved
what is the mutual recognition system for registration like? (4)
- first application made to one or more EC member state authority
- national/decentralised authorisation granted
- mutual recognition by other concerned member states authorities
- each member state issues authorisation
how does the type of MA application depend on the nature of the API? (4)
- new active substance (NCE) - full application
- biological and biotechnology products
- fixed combination application
- abridged products (generics, informed consent application, well established use application)
what must every MP have?
- summary of product characteristics (SPC), data sheet (3)- label
- patient information leaflet (PIL)
what is the summary of product characteristics (SPC)?
legal document containing factual information of MP based on data generated during development of the product
what is included in the SCP? (7)
- name, strength and pharmaceutical form
- qualitative and quantitative composition
- clinical particulars
- pharmacological properties
- pharmaceutical particulars
- name of UK MA holder
- number of UK MA, etc
what does the parallel import license (PLPI) allow?
MP with a MA to be bought in one european member state and sold in another
what must the importer hold for a PLPI? (2)
- WDL (import)
- ML (repackage + relabel)
what are the conditions that have to be met by the product for a PLPI? (5)
- not vaccine, toxin, blood product, radioactive isotope or homeopathic product
- covered by european MA, version of product already with UK MA
- same therapeutic effect
- made by, under license to UK manufacture/ member of same group of companies
- labelled and have PIL in english
what are specials?
products which have been specially manufactured or imported for treatment of individual after being ordered
who are specials ordered by? (5)
- doctor
- dentist
- nurse independent prescriber
- pharmacist independent prescriber
- supplementary prescriber
What must a manufacturer hold to make a special?
manufacturer’s special license
what is the manufacturer’s specials license like? (4)
- no advertising of products only of the service
- doctor takes responsibility for efficacy of product
- license holder takes responsibility for quality of product
- inspected by MHRA as per ML
what are investigational medicinal products? (5)
- used in clinical trials
- challenge agents (response)
- radiopharmaceuticals (imaging)
- background treatments
- MP used to assess end points
what are the type of homeopathic medicines (part VI)? (2)
- simplified scheme
- national rules scheme
what is the simplified scheme? (4)
- safety and quality demonstrated
- no medical claims or indication allowed
- restricted to products for oral and external use
- products must be sufficiently dilute for safety
what is the national rules scheme? (3)
- product can be registered with indications for relief/treatment of minor symptoms
- applications supported by data and on safety and quality with appropriate labelling
- evidence that it’s used as a homeopathic treatment in the indication sought
since when have all herbal products are requires to have a THR and MA?
30th april 2011
what are the 2 types of herbal medicines?
- traditional herbal registration (THR)
- licensed herbal medicine (needs MA)
what is a THR like? (2)
- simplified registration scheme
- needs to reach specific standards of safety and quality
what is the LHM like?
quality, safety and efficacy has been demonstrated
