Medicinal Products legislation

Which vitamin is a medicinal product ?

Rudoxon " treatment of vitamin C and iron deficiency "

Which of the following is true with regards to national marketing authorization ?

1. Application to competent authority

2. Assesment of quality , safety , efficacy

3. It is renewable

4. It is not renewable

5. Valid for 5 years then renew before 9 month expiry and then open-ended renewal

4

How is the MA renewed ?

Valid for 5 years them renew before 9 month expiry and then open-ended renewa

When is the sunset clause of MA implemented ?

1.Product not launched after 3 years

2. Product taken off market for 3 years

Name the two procedure for application of MA in multiple member states

Centralized

Decentralized / mutual recognition procedure

With regards to decentralized process what occurs ?

one EEA country takes lead and approves product.The manufacturers then applies for MA in each country based on the fact approved in lead country

What is parallel importation ?

importation from an EEA state of same medicinal product as authorised in ireland but by a different importer to the marketing authorization one

Example of parallel import

companies goes to Greece buys up cheap Pfizer medication , brings to Ireland same authorised product sellers for cheaper and undercuts Pfizer

Parallel importers require.Who grants the licence ?

Licence

Ppa on product

granted by the HPRA

Parallel distribution involves

distribution of EU product from one EEA state to another

What code does a parallel distributed product have ?

What needs to be done with product ?

who grants the licence ?

EU

Reboxed and relabeled

EMA

Which of the following is false with regards to homeopathic remedies cert of reg products

Administered oral or external

No specific therapeutic indications

Prove quality and safety

HORxxxx/xxx/xxx

Parental administation allowed

Parental administation allowed

Which of the following is false with regards to homeopathic remedies cert of reg products

1.No more than 1:10,000 mother tinciture

2.Prove efficacy

3.Parental use allowed

4.Rx only onluy all 1/100 allopathy

5. Specific therapeutic indication

2,3,5

Code for homeopathic certificate of reg

HOR

In order for a homeopathic medicinal product to be granted MA under naational rules it must

Suitable for use without diagnosis or monitoring by doctor

Prove efficuacy

Demonstrate safety

How does a homeopathic medic acinar product demonstrate efficacy ?

Used in ireland for indication sought

In order for a homeopathic medicinal product to be granted MA under naational rules it must

Refrence relevant published literature with data

State homeopathic nature of product - in food

No more than 1:10,000 mother tincture

Rx - 1% allopathy

Homeopathic medicinal product with MA code

HOAxxxx/xxx/xxx

In order for herbal product to get certificate of traditional use it must

No doctor diagnosis , prescription or monitoring ( IF NOT SUITABLE THEN NO )

Specific strength , dosage

Inhalation , oral , external

Sufficient period of traditional use

Not harmful when used for condition

What is meant by suffice it period of transitional use for herbal medications products

Al least 30 years and minimum 15 in EU

Exemptions from authorization

Clinical trials

Non-EEA import but no it mail order - tourist

Unlicensed medication in accordance with practitioner directions ( prescriber takes account )

Procuring medication - doctor/dentist

Radiopharmaceuticals

With regards to unlicensed medication which of following is false

No need for MA

Med supplied by under pharamcist supervison

No ads to public

Manufacturing controlled and meets specific requirements

Can't be imported from a non-EEA country

5 - by wholesaler authorised importer and they take responsibility

When a Dr/dentist is procuring a product which of following applies

Always needs MA

Max stock held 3L or 1kg

Administration for specific patient

2,3

When a pharamcist is procuring medication , the product must be from

Manufacturer with authorization

Radiopharmaceutical prepared from a kit do not require MA at time of administration but they must be administered

Pepared or supervised by person will administer it

Given in licensed place

With regards to outer labelling , when is the international nonproprietary name included ? What should be done if INN doesn't exist

3 active ingredients

Give common name ( braille and conventionL tesxt )

Which excipients are included in outer labelling ? What must always be included for topic eye preperations ?

active ingredients : lactose etc

Eye : all excipients

On a label which of the follow is always included

Keep out of reach and sight ofd children

Instructions for use if non-Rx

Rx med space for label

Intended for babies , children , adult

Expiry date

All except 4 - only when necessary

Exceptions to immediate packaging ( usually same details as outer however if small ) i.e Blister pack immediate labelling requirements

Name of product-strength-form

Name of holder of authorization

Expiry date

Batch number

Exceptions to immediate packaging ( usually same details as outer however if small ) i.e ampoules immediate labelling requirements

Name - strength - form ( route of admin if necessary )

Method of admin

Expiry

Batch

Contents by weight , volume , units

If a product has no outer packaging ( lactulose ) what is done

Full details on immediate packaging

Pictographs designed to clarify labelling information

Package leaflet contains

1.Identify product - i) strength -form ii) drug class

2.Therapeurtiuc indications

3.Info before medication taken i) contra-indications ii) pre-cautions iii) interactions

4. Proper use instructions i) dosage ii) route etc ii) duration iv ) action of overdose via) withdrawal

5.Decribe adverse side-effects

6.Refrence expiry - do not take

7.List of names authorised in each memeber state

8.Date of last package leaflet review

What language is package leaflet in

English

Can be in another language but must be fully translated

When seeking approval of package leaflet what needs to be demonstrated ?

Consultation with target patients

EU commissions provides guidance

Evidence clear , easy to use , legible

Which product have exemptions to packaging leaflet

Radionuclides

Advanced therapeutics

Traditional herbal medicinal products

Homeopathic medication product

Herbal medicinal product with certificate of traditional use must have what on package leaflet

Statement to effect of

product is traditional herbal use product

Use in specified indication

Based on long-term use

Consult doctor or healthcare if symptoms persist

Registered homeopathic medicinal products must

homeopathic medicinal product without approved therapeutic indications

Consult doctor if symptoms persist

No need to extra non-promotional material on packaging ( clear list )

Herbal medicines code q

TR