Pharm Y2S2 - Law Exam Part 1

Manufacture Sale Supply Import Authorisation

MHRA European Medicines Agency

Any substance(s) presented as having properties of preventing/treating disease in humans. Administrable to humans with a view to restoring/correcting physiological function or making medical diagnosis

A product with one of: marketing authorisation as a medicine Certificate of registration as homeopathic Traditional herbal registration as herbal remedy

Medicinal product with marketing authorisation, not registrable homepathic or traditional herbal

Products not easily distinguished as medicines, food supplements and cosmetics

If it contains active pharmacological substances or makes medicinal claims

Sutures Dressings Contact lens care products

Medical Device Regulations 2002

Marketing authorisation Certification of registration as homeopathic Traditional herbal registration

Required by all relevant medicinal products for sale/supply

Any product on the market prior were granted a product license of right, became marketing authorisation in 1994

New active substances Abridged- generic pre-existing products Biological/biotechnology products

Name/address of applicant Name/address of manufacturer Name of medicinal product Details of product constituents Evaluation of potential environmental risks Data on indications, contraindications, clinical studies etc Pharmacovigilence system SPC Packaging Leaflet Proposed legal category

5 years

Adverse reports Sale/supple Source of all materials Periodic safety update

Where it causes confusion, is misleading or otherwise unsafe

20-80 patients to determine dosage, side effects etc 100-300 patients to determine efficacy 1000-3000 patients to confirm dose, side effects, indication post marketing studies

Easily legible Comprehensible Indelible Where there is more than one language, same particulars must appear in each Name expressed in braille on outer packaging

Name of product Strength and form Intended use in... Common name of substances up to 3 Statement of active substances (qualitative and quantitative) per unit dosage Form/contents by weight or volume List of excipients (all in injectables, topical and eye preparations) Method/route of administration Space to indicate prescribed dose Store out of reach and sight of children Special warnings Expiry date Storage/disposal requirements MA number and holder details Batch number Instructions for use where it is not a POM

Name Strength and form Intended for... Common name of active substances up to 3 Name of MA holder Expiry date Batch number

‘Contains paracetamol’ unless stated in the name ‘Do not take more than the medicine labels tells you to. If you do not get better consult your doctor’ adjacent to directions for use ‘Talk to a doctor at once if you take too much of this medicine, even if you feel well. (This is because too much paracetamol can cause delayed and serious liver damage)’ (only requirement where there is no leaflet included)

Manufacture and assemble licensed products (with MA) Export and import to countries outside the EEA

Manufacture and assemble unlicensed products Supply made in response to unsolicited order for patient under direct care of requestee with specific needs

Manufacture and assemble products for phases 1-3 of clinical trials

For exempt advanced therapy | For non-orthodox practitioners

Wholesale of POM, P, GSL and traditional herbal medicines | Import of unlicensed products from inside EEA

Holder of WL relating to particular products Holder of EEA equivalent license Persons who may lawfully sell, supply or administer medicines

5 years

Pharmacist may manufacture and assemble products Doctors and dentists may prepare and assemble products Nurses and midwives may assemble products Herbalists may prepare and assemble herbal medicines MUST- be within the course of their practice, for patient under their care who is present, in lockable premises

Manufacturers marketing their own products for which they hold MA Import to specific individual or products intended to be re-exported without alteration

Promoted to practitioners Oral administration where there is specific written benefit for disease Vitamins with no written direction for dosage Vitamins with daily doses exceeding specific values

Containing antibiotic 0.004% or more of any hormone Hexachlorphane over 0.1% (providing cautions are labelled clearly below 0.1%) Resorcinal over 1%

Advertising standards authority Proprietary association of GB Prescription medicines code of practice authority

Comply with limited number of annual supples Marked as free sample Maximum smallest presentation available for sale Supply against written and signed request

Medicinal product whose active ingredients are herbal substances or preparations

Plant, algae, fungi, lichen or unprocessed exudate defined by its botanical name and the part of the plant it came from

Obtained by subjecting a herbal substance to processes such as extraction, concentration, distillation and fermentation

Essential oils Tinctures Extract

No need to be registered with Health and Care Professionals Council

Licensed, with MA Registered traditional Unlicensed, not produced industrially

Dealers | Practitioners

For an individual based on a one-to-one consultation with said individual to meet their needs. Practitioner accepts liability

Restrictions to sale/supply do not apply if the product is manufactured or prepared by a herbalist for administration to an individual who is present

Aristolochia Kava-kava Senecio

Dictates the herbal substances that cannot be sold/supplied

Areca Canadian hemo Embelia Male fern Strophanthus

Dictates the herbal substances that cannot be sold/supplied over a certain specified dose/strength

Aconite Adonis vernalis Belladonna herb Conium leaf Ephedra Lobelia

Also known as monkshood, a poisonous plant that is particularly toxic to the heart

Pharmacists may sell from a registered premises substances containing part I or II substances

GSL herbals Registered traditional herbal medicines Foods/cosmetics

Transition of herbal medicines to become registered, happened over 7 years making registration legal from April 2011

Allows use of herbal medicines without the need for a medical practitioner to diagnose or monitor treatment

For oral, topical or inhaled administration | In medical use for 30 years and continuous use in the EU for 15 years

Clearly stated that it is a THMP Use for specific purposes Consult doctor where symptoms do not improve or adverse effects occur that are not stated

Use is based upon long standing used as a traditional remedy

Products based on the theory that 'like cures like' at low dilutions No therapeutic indication is permitted

Registration of homeopathic medicinal products based on safety and efficacy for self treatment of minor symptoms and conditions

If pre-existing upon implementation of Medicines Act, given a product license of right

Globally harmonised system for labelling and classification of chemicals

Classification, labelling and packaging regulation 2008, came into full effect in 2015

Explosive Flammable Oxidising

Toxic Harmful Corrosive Irritant Carcinogenic Mutagenic

Chemicals in their finished state intended for use as medicines, medical devices, food, cosmetics, feeding stuffs

Tell anyone using/handling of hazards | Brief precautionary advice

Substance name and quantity Contact details of supplier Firmly affixed Clear and indelible To read horizontally

Must prevent chemical escaping Not be adversely affected by chemcial Strong enough to withstand normal handling If for general sale, child resistant with tactile danger warnings

Liquid phenol Pyrogallol Monochloroacetic acid Salicylic acid Regulated as medical devices if placed on the market with medicinal claims

Arsenic Strychnine Regulated by HMR 2012

Poisons Act 1972 splits poisons into 4 lists, regulated and reportable explosive precursors and poisons

To purchase regulated poisons or explosive precursors for home use, to purchase certification and ID is required

An EPP licence from the home office, application requires ID, proof of address, certificate of good standing and a doctor's report

Hydrogen peroxide, potassium/sodium chlorates, nitric acid

Sulphuric acid, acetone, nitrates

Hydrogen cyanide, lead acetates, barium salts

Ammonia, hydrogen chloride, phenols

Should be stored in a cupboard or drawer solely dedicated to chemicals, not accessible to the public and no food should be stored below

Made unsuitable for drinking by the addition of denaturants, methylated spirits

Alcoholic liquor duties act 1979 | Denatured alcohol regulation 2005

Alcohol of any description, including liquor mixed with alcohol, and all mixtures, compounds and products made with alcohol.

Only by a person holding a justice's license

Completely Industrial Trade specific

Mineralised methylated spirits, no supply of usage limits/regultions Per every 100 parts volume, 3 parts methylethylketone, 1 gramme denatonium beznoate May contain methyl violet as dye

95% alcohol | 5% wood naphtha

Approved to meet trade specific needs, 11 approved formulations

Written authorisation required from revenue and customs which is valid indefinitely. States what they can receive and its purpose of use, may specify storage conditions

Yes, in quantities below 20L

Prescriptions may be dispensed as normal Written orders from practitioners has no quantity limit but the classification and quantity must be provided Patients/prescribers do not require authorisation

89-85% ethanol 1-5% methanol No direct controls but must be labelled for external use only

Records should be kept in stock book | Can have medical use

Usually 70% | No specific requirements

Veterinary Medicines Regulation 2013 | Misuse of Drugs Act 1971

Veterinary medicines directorate | National office of animal health

Any substance presented to have properties for treating or preventing disease in animals with marketing authorisation

Prescription only medicine that can be supplied by veterinarian, pharmacist or suitably qualified person

Veterinary P product for non-food producing animals

Authorised veterinary medicine for general sale

If each individual transaction is authorised before supply or they are satisfied that the person who is handing over is competent

An animal medicine advisor who has passed the appropriate examinations to prescribe