Medicines Authority (Fees) (Amendment) Regulations, 2014

L.N. 305 of 2014

MEDICINES ACT

(CAP. 458)

Medicines Authority (Fees) (Amendment) Regulations, 2014

IN exercise of the powers conferred by article 106 of the

Medicines Act, the Parliamentary Secretary for Health and the

Minister for Social Dialogue, Consumer Affairs and Civil Liberties,

with the concurrence of the Minister for Finance, have made the

following regulations:-

The title of these Regulations is the Medicines Authority

(Fees) (Amendment) Regulations, 2014, and these regulations shall

be read and construed as one with the Medicines Authority (Fees)

Regulations, hereinafter referred to as the "principal regulations".

Immediately after subregulation (4) of regulation 3 there

shall be added the following new subregulation

"(5)

In exceptional circumstances and at the discretion

of the Chief Executive Officer of the Medicines Authority, in

consultation with the designated Minister, waivers for fees due

under these regulations may be granted.".

Schedule 1 of the principal regulations shall be amended as

follows

(a)

for the table

"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

Additional strength/pharmaceutical form (applied for at the same

time)

there shall be substituted the following table

"Type of Application

MUTUAL RECOGNITION PROCEDURE/

DECENTRALISED PROCEDURE

(Malta Concerned Member State)

New Applications (per product)

All applications

(b) for the table

"Type of Application

MUTUAL RECOGNITION PROCEDURE/

DECENTRALISED PROCEDURE

(Malta Reference 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(1) of Directive 2001/83/EC

Article 10(3) of Directive 2001/83/EC

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

Article 10 (4) of Directive 2001/83/EC

Additional strength/pharmaceutical form (applied for at the same

time)

Line extension applied for after grant of Marketing Authorisation

Parallel application (applied for at the same time)

Repeat use MRP

Application withdrawn during validation

Duplicate application

Change from Malta Concerned Member State to Reference

Member State

there shall be substituted the following table

"Type of Application

MUTUAL RECOGNITION PROCEDURE/

DECENTRALISED PROCEDURE

(Malta Reference 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(1) of Directive 2001/83/EC

Article 10(3) of Directive 2001/83/EC

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

Article 10(4) of Directive 2001/83/EC

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

Additional strength (applied for at the same time)

Additional pharmaceutical form (applied for at the same time)

Line extension applied for after grant of Marketing Authorisation

Parallel application (applied for at the same time)

Repeat use MRP

90% of relevant

Application withdrawn during validation

fee is refunded

Duplicate application

Change from Malta Concerned Member State to Reference

Member State

* 30% of fees are discounted for Micro Enterprises as defined in Commission

Recommendation 2003/361/EC of 6 May 2003 concerning the definition of

micro, small and medium-sized enterprises [Official Journal L 124 of

L-Iskeda 2 tar-regolamenti prinċipali għandha tiġi emendata

Jemenda l-

Iskeda 2

kif ġej

regolamenti

prinċipali.

it-tabella

Dritt

"Tip ta’ Varjazzjoni

€*

Il-bidla fl-isem u, jew fl-indirizz ta’ detentur ta’ awtorizzazzjoni ta’

116.47

Il-bidla fl-isem tal-prodott ta’ mediċina

116.47

Il-bidla fl-isem tas-sustanza attiva

116.47

Il-bidla fl-isem u, jew indirizz ta’ manifattur tas-sustanza attiva

meta ma jkun hemm disponibbli ebda ċertifikat ta’ adattabilità ta’

Farmakopea Ewropea

116.47

Il-bidla fl-isem u, jew indirizz ta’ manifattur tal-prodott lest

116.47

Tip I (oħrajn) Nazzjonali

Nazzjonali

L-oħrajn kollha ta’ Tip IA 3

174.70

L-oħrajn kollha ta’ Tip IB3

349.41

Tip II 4 Nazzjonali

Nazzjonali

815.28

Tip II Kompless 5

6,056.37

2 Il-varjazzjonijiet għal prodotti li kienu awtorizzati matul l-arranġament tran-

sitorju u l-linji ta’ estensjoni tagħhom jinsabu inklużi fid-dritt li jitħallas fis-

sena, sakemm il-varjazzjoni tkun diġà approvata f’xi pajjiż ieħor tal-UE/

Żona Ekonomika Ewropea.

3 Għal applikazzjonijiet għal varjazzjoni ta’ Tip 1A u 1B ikun jgħodd ‘skont’

bl-ingrossa meta jsiru għadd ta’ applikazzjonijiet simultanji għal varjazz-

jonijiet identiċi. L-ewwel minn dawk l-applikazzjonijiet titħallas bir-rata

sħiħa murija hawn qabel filwaqt li t-tieni applikazzjoni u applikazzjonijiet

sussegwenti jitħallsu b’rata ta’ 50%.

4 Varjazzjonijiet biex jinbidel strain ta’ vaċċini virali jitħallsu bir-rata ta’ 35%

tad-drittijiet murija għall-varjazzjonijiet fil-kumpless ta’ Tip 2. It-tnaqqis

fid-dritt biex jinbidel strain ta’ vaċċini virali ma jkunx jgħodd meta Malta

tkun l-Istat Membru ta’ referenza fi proċedura ta’ rikonoxximent reċiproku/

deċentralizzata.

5 Għal applikazzjonijiet għal varjazzjoni ta’ Tip 2 ikun jgħodd ‘skont’ bl-

ingrossa meta jsiru għadd ta’ applikazzjonijiet simultanji għal varjazzjonijiet

identiċi. L-ewwel minn dawk l-applikazzjonijiet titħallas bir-rata sħiħa

murija hawn qabel filwaqt li t-tieni applikazzjoni u applikazzjonijiet susseg-

wenti jitħallsu b’rata ta’ 50%.",

għandha tiġi sostitwita bit-tabella li ġejja

B B 4059

"Varjazzjoni (ta’ prodotti awtorizzati bi Proċedura Nazzjonali*

u Proċeduri Ewropej fejn Malta hija l-Istat Membru ta’

€

Referenza fil-MRP u DCP)

Tip I

Tip IA

Tip IB

Tip II

Tip II Sempliċi

Tip II Kumplessi

4,000

* Fejn mal-applikazzjoni ma tiġix sottomessa approvazzjoni minn Stat Mem-

bru ieħor tal-UE għal-varjazzjoni inkluża fl-iskop tal-applikazzjoni

Għal-applikazzjonijiet għal-varjazzjonijiet miġbura (skont il-Komunikazz-

joni tal-Kummissjoni Ewropeja – Linji Gwida fuq id-dettalji tal-firxa ta’

kategoriji tal-varjazzjonijiet fit-termini tal-awtorizzazzjoni ta’ prodotti

mediċinali għall-użu fil-bniedem u fl-annimali) drittijiet jiġu miġbura għal

kull varjazzjoni inkluża fil-grupp għall-ewwel awtorizzazzjoni (numru tal-

awtorizzazzjoni/numru tal-proċedura) imma mhux għal qawwiet u forom

addizzjonali li huma suġġetti għall-istess varjazzjoni";

Minnufih wara n-nota f’qiegħ il-paġna fl-Iskeda 3 għandu

Jemenda l-

Iskeda 3tar-

jiżdied dan li ġej

regolamenti

prinċipali.

"Sensara ta’ prodotti mediċinali u importaturi u

distributuri ta’ sustanzi attivi huma suġġetti għad-drittijiet

kollha applikabbli għal distributuri bl-ingrossa.".

Fir-regolament 12 tar-Regolamenti dwar il-Farmakoviġilanza

Emenda

konsegwenzj

għandu jiżdied il-paragrafu li ġej

ali għar-

Regolamenti

dwar il-

Farmako-

viġilanza,

"Detenturi ta’ Awtorizzazzjonijiet għat-tqegħid

fis-suq għandhom iħallsu l-obbligi kif imposti taħt ir-

Regolamenti dwar il-Farmakoviġilanza.".

05.2003].

* 30% discount applies if 3 or more new procedures are submitted during a

period of 12 months. Discount is given upon submission of the 3 rd applica-

tion.

* Above discounts cannot be availed of at the same time";

(c)

for the table

"Type of application

Malta Reference Member State in the MRP/DCP

Renewal application (per product)

Annual maintenance fee (for each form and strength)

First strength or form

Additional strengths and forms (each)

Additional parallel procedures (each)

there shall be substituted the following table

"Malta Reference Member State DCP/MRP – Other activities

Renewal application per product

Annual maintenance fee (for each form and strength) in 2015 and

beyond †

†

Activities covered include pharmacovigilance";

(d) for the table

"OTHER ACTIVITIES

Renewal application per product (if applicable)

National procedure

Mutual Recognition Procedure/Decentralised procedure

Annual fee (for each form/strength)

Market Authorisation Transfer

there shall be substituted the following table

"OTHER ACTIVITIES

Renewal application per product (where applicable)

National procedure

Mutual Recognition Procedure/Decentralised procedure (Malta

Concerned Member State)

Other activities

Annual maintenance fee (for each form/strength) (All Marketing

Authorisations) in 2015 †

Annual maintenance fee (for each form/strength) (All Marketing

Authorisations) in 2016 †

Market Authorisation Transfer

†

Activities covered include pharmacovigilance";

(e)

for the table

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

(Marketing Authorisation) Applications in accordance with

article 126a of Directive 2001/83/EC (for each strength or

pharmaceutical form)

Issue of authorisation

Renewal of authorisation (every 5 years)

Annual fee

there shall be substituted the following table

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

(Marketing Authorisation) Applications in accordance with

article 126a of Directive 2001/83/EC

New application/renewal # received in 2015 and beyond

Annual maintenance fee in 2015

Annual maintenance fee in 2016 and beyond

Fast track application for authorisation (10 working days)*

#

Renewal must be submitted 6 months before expiry (submitted every 5

years).

* Timeline applies from positive validation of the application. The Medicines

Authority may extend the timeline in exceptional circumstances.";

(f)

for the table

"Parallel importation

New product (each strength/form per country)

Annual fee

Renewal of authorisation (every 5 years)

there shall be substituted the following table

"Parallel importation licence (per strength/form/source

country)

New parallel import licence application/renewal # received in 2015

and beyond

Annual maintenance fee in 2015

Annual maintenance fee in 2016 and beyond

#

Renewal must be submitted 6 months before expiry (to be submitted every 5

years)";

(g) for the table

"Clinical trial application

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

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

1,397.62

Phase 4 patient trial

(232.94)1

93.17

Amendment/s

Fees in brackets are for applications for academic research without financial

support from industry. Decision will be at the discretion of the Licensing

Authority";

there shall be substituted the following table

"Clinical trial application

€

1,500 1

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

2,000 1

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

1,500 1

Phase 4 patient trial

150 1

Amendment/s

Fees for academic research without support from industry benefit from a fee

exemption of 70% of full fee. Decision will be at the discretion of the Medi-

cines Authority";

(h) for the table

"Other

€

Pre-submission meetings with Malta as Reference Member State

in MRP/DCP/national procedures (Scientific advice)

2,328.37",

there shall be substituted the following table

"Scientific advice/pre-submission meetings

€

Malta Reference Member State/Rapporteur in European procedures

or for national procedures

2,300".

4. Schedule 2 of the principal regulations shall be amended as

Amends

Schedule 2

follows

of the

principal

regulations.

for the table

"Variation Type

€*

National 2

Type I

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

116.47

holder

Change in the name of the medicinal product

116.47

Change in the name of the active substance

116.47

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

116.47

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)

All other type IA

All other type IB

Type II

Type II Simple

Type II Complex

2 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.

3 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%.

4 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.

5 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%.";

there shall be substituted the following table

"Variation Type (for national procedures* and procedures

where Malta as Reference Member State in the DCP and MRP)

Type I

Type IA

Type IB

Type II

Type II Simple

Type II Complex

* Where application is not accompanied by an acceptable EU approval for the

variation included in the scope of the application

For grouped variations (in accordance with the Communication from the

Commission – Guideline on the details of the various categories of

variations to the terms of marketing authorisations for medicinal products

for human use and veterinary medicinal products) fees will be charged for

each variation included in the group for the first marketing authorisation

(MA number/Procedure number) but not for additional strengths which are

included in the group and which are the subject of the same variations.";

5. Immediately after the last footnote in Schedule 3 there shall

Schedule 3

be added the following

regulations.

"Brokers of medicinal products and importers or

distributors of active pharmaceutical ingredients shall be

subjected to all fees applicable for wholesale dealers.".

6. In regulation 12 of the Pharmacovigilance Regulations,

Consequential

amendment to

there shall be added the following paragraph

covigilance

Regulations,

"Marketing authorisation holders shall pay fees for

pharmacovigilance obligations as levied under the

Medicines Authority (Fees) Regulations).".

€0.81