Medicines Authority (Fees) Regulations, 2006

L.N. 315 of 2006

MEDICINES ACT

(CAP. 458)

Medicines Authority (Fees) Regulations, 2006

IN exercise of the powers conferred by article 106 of the Medicines

Act, the Minister of Health, the Elderly and Community Care, with the

concurrence of the Prime Minister and Minister of Finance, has made

the following regulations>-

The title of these regulations is the Medicines Authority (Fees) Citation.

Regulations, 2006.

Interpretation.

For the purposes of these regulations –

(Regulation 3)

PRODUCT AUTHORISATION FEES AND OTHER ACTIVITIES

Type of Application

MUTUAL RECOGNITION PROCEDURE/

DECENTRALISED PROCEDURE

(Malta Concerned Member State)

New Applications per product

Article 8.3 of Directive 2001/83/EC: New active substance

Article 8.3 of Directive 2001/83/EC: Known active substance

Article 10 (a) of Directive 2001/83/EC

Article 10 (b)of Directive 2001/83/EC

Article 10 (c) of Directive 2001/83/EC

Article 10 (5) of Directive 2001/83/EC (new indication)

Line extension of a medicinal product authorised by the Mutual

Recognition/Decentralised procedures

Additional strength/pharmaceutical form (applied for at the same

time)

Type of Application

NATIONAL PROCEDURE

Article 8.3 of Directive 2001/83/EC: New active substance

Article 8.3 of Directive 2001/83/EC: Known active substance

Article 10 of Directive 2001/83/EC

Article 10 (a) of Directive 2001/83/EC

Article 10 (b) of Directive 2001/83/EC

Article 10 (c) of Directive 2001/83/EC

Article 10 (5) of Directive 2001/83/EC (new indication)

Additional strength/pharmaceutical form (applied for at the same

time)

Line extension of a product authorised by the Mutual

Recognition/Decentralised Procedures

Type of Application

MUTUAL RECOGNITION PROCEDURE/

DECENTRALISED PROCEDURE

(Malta Reference Member State)

Outgoing supplement over the fee for National applications

Type of Application

OTHER ACTIVITIES

Renewal application per product (if applicable)

National Procedure

Mutual Recognition Procedure/Decentralised Procedure

Annual Fee (for each form and strength, for all marketing

authorisations)

Market Authorisation Transfer

Type of Application

Traditional Herbal Medicinal Products

National Simplified Registration for Traditional Herbal Medicinal

Product (Quality assessment only)

Variations

Administrative

Technical

Type of Application

Authorisation in line with article 4(2) of the Medicines

(Marketing Authorisations) Regulations in accordance with

article 126(a) of Directive 2001/83/EC of the European

Parliament and of the Council of 6 November 2001 on the

Community Code relating to medicinal products for human use,

as amended by Directive 2004/27/EC of the European

Parliament and of the Council of 31 st March 2004

Issue of authorisation

Renewal of authorisation (every 5 years)

Annual fee

Homeopathic Product

New Product (single stock)

New Product (for 2 or more stocks)

Variations

Administrative

Technical

Parallel Import Licence

New Product (for each strength, pharmaceutical form per country)

Annual Fee

Renewal (every 5 years if applicable)

Clinical Trial Application/Trial

Phase 1,2 or 3 patient trial with a known product

Phase 1,2 or 3 patient trial with a new product

Phase 4 patient trial

Amendment/s

Classification Committee per product

Pre-Submission Meetings with Malta as Reference Member State

in

MRP/DCP /national procedure (Scientific advice)

Fees in brackets are for applications for academic research without financial support from industry. Decision

will be at the discretion of the Licensing Authorit

“Active Pharmaceutical Ingredient” (API) means any

substance or mixture of substances intended to be used in the

manufacture of a medicinal product and that, when used in the

production of a medicinal product, becomes an active ingredient

of the said product. These substances are intended to furnish

pharmacological activity or other direct effect in the diagnosis,

cure, mitigation, treatment or prevention of disease or to affect the

structure and function of the body<

“API manufacturer” means a person, group of persons or

company involved in the manufacture of active pharmaceutical

ingredients<

“Certificate of a pharmaceutical product (CPP)” or “Export

Certificate” means a certificate, complying with the format

specified by World Health Organisation, providing details about a

single named medicinal product, which may be licensed or

unlicensed in Malta. It provides details about the product and its

manufacture including, but not limited to, the marketing

authorisation (MA) holder, where applicable, the active ingredients

and excipients, the manufacturing and packaging sites and whether

or not the product is placed on the market in Malta<

“Concerned Member State” means a Member State or States

in which mutual recognition is sought in the Mutual Recognition

and Decentralised procedures<

“Directive 2001#83#EC” means Directive 2001#83#EC of the

European Parliament and of the Council of 6 November 2001 on

the Community code relating to medicinal products for human use,

and its amendments as amended by Directive 2004#27#EC and

Directive 2004#24#EC<

“Extension application” is an application for changes that

cannot be considered as variations. These changes are listed in

Annex II of Regulations 1084#2003#EC and 1085#2003#EC and

must fulfil the conditions set out therein<

“Follow-up inspections” refers to inspections other than those

referred to as major inspections<

“GMP Certificate” means a certificate issued by the Medicines

Authority for the purpose of confirming to a manufacturer the

overall conclusion of an inspection with respect to compliance with

good manufacturing practice<

“Good clinical practice inspection” means an inspection

performed to assess the standards for the design, conduct,

performance, monitoring, auditing, recording, analysis and

reporting of clinical trials so as to provide assurance that the data

and reported results are credible and accurate, and that the rights,

integrity and confidentiality of trial subjects are provided<

“Herbal medicinal product” means any medicinal product,

exclusively containing as active ingredients one or more herbal

preparations, or one or more such herbal substances in combination

with one or more such herbal preparations<

“Importer” means any person or group of persons or company

involved in the importation of Medicinal products obtained from

a source outside the European Union or the European Economic

Area<

“Importing activity” is the action by which medicinal products

sourced from outside the European Union or the European

Economic Area are obtained, stored and distributed<

“Major inspection” refers to inspections carried out for the

first time in a particular area or site, or inspections to already

existing sites that had major variations or alterations<

“Marketing authorisation transfer” is when a marketing

authorisation is transferred from the existing Marketing

Authorisation Holder to another using a transfer procedure. A

transfer may occur either during or after issue of a marketing

authorisation<

“Partial Manufacturing” has the same meaning as”“assembly”

in Medicines Act<

“Pharmacovigilance inspection” means an inspection carried

out to assess the pharmacovigilance programme of a Market

Authorization Holder during which the following are assessed>

(a) monitoring of adverse drug reactions endorsed by

company for its licensed products<

(b) the assessment of risk and benefits of medicines

used to determine what action should be taken to improve

their safe use<

(c) supply of information to optimise safe and effective

use of medicines<

(d) monitor impact of any action taken by the company<

“Reference Member State” means the Member State, which

has produced the assessment report for a given medicinal product,

which serves as the basis for the Mutual Recognition and

Decentralised Procedures<

“Traditional Herbal Medicinal Product” is a herbal medicinal

substance that fulfils the conditions laid down in the Herbal

L.N. 379 of 2005.

Medicinal Products Regulations, 2005<

“Variation relating to a pharmaceutical activity” means any

change pertaining to the related activity that may or may not require

an inspection. Variations not requiring an inspection are those

changes in the administrative details appearing on the licence, such

as changes in name of company or change in names of key

personnel. Variations that require an inspection are changes that

can have an effect on the quality system of the company and, or on

the quality of the product directly or indirectly which hence requires

an inspection, such as in a change in a particular stage of the

manufacturing process or installation of new equipment<

“Variation to the terms of a marketing authorisation” means

an amendment to the contents of the documents referred to in

regulations 5 to 9 of the Medicines (Marketing Authorisation)

Regulations, 2006>

(1) “Type I variation” means a minor variation listed

in Annex I of Regulation 1084#2003#EC and which fulfils

the conditions set out therein<

(2) “Type II variation” means a variation that cannot

be deemed to be a minor variation or an extension of the

marketing authorisation<

(3) “Type II Complex variation” means a variation,

when it falls within one or more of the following descriptions>

(a) the application relates to the results of clinical

trials or other data (including pharmacological and

toxicological tests as well as extensive evidence from

post marketing experience or publications) that need to

be newly assessed<

(b) the application is supported by substantial

amounts of data, that have not previously been assessed<

(c) the application relates to changes in

indications for use in a therapeutic area for which the

product was not previously indicated for use<

(d) the application relates to changes in

indications for use in respect of an organ, or any other

part, of the human body for which the product was not

previously indicated for use<

(e) the application is supported by data which

comprises or includes the results of clinical trials or

physico-chemical, microbiological or pharmacological

and toxicological tests<

(f) the application relates to an increase in the

maximum dose<

(g) the application relates to a new dosage

regimen<

(h) the application relates to a change in the

method of sale or supply of an active ingredient from

prescription only to pharmacy sale<

(i) the application relates to a change in the

conditions of prescribing<

(j) the application relates to the removal of a

contra-indication<

(k) the application relates to an increased duration

of treatment<

(l) the application relates to a change in the route

of administration of the same dosage form<

(m) the application relates to a new route of

synthesis that has not previously been assessed and a

European Pharmacopoeia Certificate of Suitability is not

available for the active ingredient<

(n) the application relates to a new method of

sterilisation of the product<

(o) the application relates to a new container

materials for a sterile product<

(p) the application relates to a new active

ingredient manufacturer not previously approved to

manufacture the active ingredient concerned and who

does not hold a European Pharmacopoeia Certificate of

Suitability for the substance concerned<

(q) the application relates to a major formulation

change which affects more than one section in the Part

II dossier and, or requires a re-evaluation of the safety

or efficacy of the product, such as –

(i) a change in more than one excipient,

except for a change in a key excipient (such as a

preservative, release-controlling excipient, or

stabiliser)<

(ii) when a change in the key excipient alone

will be regarded as a major formulation change<

(iii) the inclusion for the first time of a novel

excipient not used before in any product<

(iv) a change which requires an in-vivo

bioavailability study to be carried out<

(v) a change which results in a change to the

therapeutic characteristics of the product<

(r) the application relates to change in the method

of manufacture of the active ingredient which introduces

new impurities or changes the level of impurities and

which requires further qualification in safety studies<

(s) the application relates to any change in the

source materials, method of manufacture or analytical

procedures for a product of biological or biotechnological

origin which might significantly affect the quality of the

product<

(t) the application relates to a change in the

qualitative composition of the immediate packaging of

a sterile product, where the container material has not

been previously approved for such use<

(u) the application relates to the introduction of a

novel method of analysis<

(v) the application relates to a new manufacturer

or process for a Flu Vaccine<

“Wholesale dealer” means any person or group of persons or

company involved in the wholesale dealing activity<

“Wholesale dealing activity” has the same meaning

as”“wholesale distribution” in the Medicines Act.

(Regulation 3)

VARIATION FEES PER PRODUCT

Fee

Variation Type

Lm

National²

Type I

Change in the name and, or address of the marketing authorisation

holder

Change in the name of the medicinal product

Change in name of the active substance

Change in the name and, or address of a manufacturer of the active

substance where no European Pharmacopoeia certificate of suitability

is available

Change in the name and, or address of a manufacturer of the finished

product

Type I (Other)

National

All other Type IA 3

All other Type IB 3

Type II 4

National

Type II Simple 5

Type II Complex 5

For products authorised by the mutual recognition procedure/decentralised procedure (Malta Reference Member State) there is

a 20% additional fee to the national fee. The variations for products that were authorised during the transitional arrangement

and their line extensions are included in the annual fee, provided that the variation is already approved in another European

Union/European Economic Area country.

For type 1A and 1B variation applications a bulk 'discount' applies where a number of simultaneous applications are made for

identical variations. The first of those applications is charged at the full rate shown above and second and subsequent

applications are charged at 50%.

Variations to change the strain in viral vaccines are charged at 35% of the fees shown for type 2 complex variations. The

reduction in fee to change the strain in viral vaccines will not apply when Malta is the reference member state in a mutual

recognition/decentralised procedure.

For type 2 variation applications a bulk 'discount' applies where a number of simultaneous applications are made for identical

variations. The first of those applications is charged at the full rate shown above and second and subsequent applications are

charged at 50%.

(1) There shall be paid to the Medicines Authority, in respect

of a marketing authorisation and related activities, the fees specified in

Schedules 1, 2, 3 and 4 of these regulations.

(2) Such fees shall not include any fees charged by other

competent authorities in relation to any documentation, reports, or

services required by the Medicines Authority for final issue of

authorisations and licences.

(3) Any additional expenses incurred by the Medicines

Authority shall be charged separately.

(Regulation 3)

INSPECTORATE FEES

Fee per type of Licence

Lm

Activity

Issue of new

(involving an inspection in Malta or within the European

licence and, or

Annual renewal

Union/European Economic Area)

major initial

Inspection 6

GOOD MANUFACTURING PRACTICE 8

Issue of licence and annual renewal

Full manufacture

Small (less than 15 employees 9 )

Medium (15 to 75 employees )

Large (76 to 200 employees )

Super (more than 200 employees )

Partial manufacturing

Issue of new

Activity

licence and, or

Annual renewal

(involving an inspection in Malta or within the European

major initial

Union/European Economic Area)

Inspection 6

IMPORTATION, WHOLESALE DEALING

Issue of licence and annual renewal

Import 10

Wholesale

PHARMACY

Issue of pharmacy licence and inspection every year

1998 and L.N. 486

(includes all follow up and other inspections)

Variation to pharmacy licence

OTHER ACTIVITIES

(Frequency as required and involving an inspection in Malta or Initial Inspection

within the European Union)

Good Clinical Practice (clinical trials) / centre / trial

Pharmacovigilance inspections

Activity

(involving an inspection in a third country outside the

Fee per type of Licence (Lm)

European Union/European Economic Area 11 )

Issue of new

GOOD MANUFACTURING PRACTICE

licence and, or

Annual renewal

Issue of licence and annual renewal

major initial

of licence 7

Inspection 6

Lm5000 plus

Lm1500 plus

Lm250

Lm250

per day per

per day per

inspector 12

inspector 12

Full manufacture

Lm4000 plus

Lm1000 plus

Lm250

Lm250

per day per

per day per

inspector 12

inspector 12

Partial manufacturing

OTHER ACTIVITIES

Follow up and

(Frequency as required and involving an inspection in a third Initial Inspection

routine

country 11 )

Inspections

Lm400 plus

Lm250

Lm600 plus Lm250

per day per

per day per

Good Clinical Practice (clinical trials) / centre / trial

inspector 12

inspector 12

Lm400 plus

Lm600 plus Lm250

Lm250

per day per

per day per

inspector 12

inspector 12

Pharmacovigilance inspections

ADMINISTRATIVE ACTIVITIES

Fee

Lm

Variations (not requiring an inspection)

Issue of CPP`s

Issue of CPP`s (fast track) 13

Issue of GMP certificates (not requiring an inspection)

Supervision of destruction of pharmaceutical waste

Includes issue of licence and inspection on a first time basis

Includes inspections for renewal of licence, routine inspections and other necessary inspections e.g. to investigate a complaint,

following a variation

Includes manufacture of finished dosage forms, Active Pharmaceutical Ingredients and Investigational Medicinal Products.

When a company additionally manufactures IMP`s and a separate inspection is required the fee for this service shall be charged

at 25% of that for initial inspections

Include all the personnel employed within the company

Applications for an import authorisation by a company already in possession of a manufacturing or wholesale dealer licence

will be charged at 50% of the normal applicable rates for import activities

For applications involving an inspection in a third country outside the European Union the applicant has to additionally cover

for the flight and all accommodation expenses of the inspectors

Includes days spent for actual inspection and for travel

This fee applies for the issue of CPP`s within 48 hours

For the purpose of these regulations, products which were on

the derogation list and were granted a marketing authorisation through

the transitional PMA#MA process prior to 31 st December, 2006 and

their line extensions, will be charged fees as applicable to the mutual

recognition procedure (Malta Concerned Member State), provided that

the authorisation requested would have already been approved in at

least one other Member State. Alternatively, national fees shall apply.

(Regulation 3)

GENERAL

Activity

Fee

Lm

Consultation (per man hour)

Issue of original copies of

licences/certificates

Appeals

Appeals to Medicines Review Board*

5,000

(*Fee for appeals will be fully refunded if appeal is successful)

Mitbug[ fl-Istamperija tal-Gvern — Printed at the Government Printing Press

The Marketing (Authorisation) Fees Regulations, 2003 and Repeals L.N. 372

of 2003 and

the Medicines Authority (Fees) Regulations, 2006 are hereby repealed. L.N. 26 of 2006.