1 Title, commencement and extent

These Regulations may be cited as the Plant Protection Products (Fees) (Amendment) Regulations 2002, come into force on 30th November 2002 and extend to Great Britain.

NOTES
Initial Commencement
Specified date

Specified date: 30 November 2002: see above.

2 Amendment to the Plant Protection Products (Fees) Regulations 2001

2Amendment to the Plant Protection Products (Fees) Regulations 2001

(1)    The Plant Protection Products (Fees) Regulations 2001 shall be amended in accordance with this regulation.

(2)    In the Schedule, Item A(2) after row (h) there shall be inserted a new row (i) as follows—

ItemType of examinationAmount
“(i)a Parallel Import application (Note 28)£710 (Note A) (Note B)”

(3)    In the Schedule, Item A(4)(c)(iii) (parallel import verification), in the column “Amount” for the figure £425 there shall be substituted the figure £300.

(4)    In the Schedule, Item B(2)(a) (relating to processing and evaluation of a full data package), in the column “Amount” after “(Note C)” there shall be inserted “(Note F)”.

(5)    In the Schedule, Item C(1) (relating to the application and inspection for initial official recognition of a test facility) in the column “Amount” for the figure £1,120 there shall be substituted the figure £1,500.

(6)    In the Schedule, Item C(2) (relating to the application and inspection for renewed recognition of a test facility) in the column “Amount” for the figure £840 there shall be substituted the figure £1,500.

(7)    In the Schedule, Item C, after the row (2) there shall be inserted a new row (3) as follows—

ItemType of examinationAmount
“(3)for each re-inspection following an inspection under item C(1) or (2)£1,125”.

(8)    In the Notes (numbered) to the Schedule, in Note 5, following the text there shall be added the following words—

“A Fast application does not include a Parallel Import application as described in Note 28.”.

(9)    In the Notes (numbered) to the Schedule, after Note 27 there shall be inserted a new Note 28 as follows—

“28

A Parallel Import application is one which would be a Fast application as described in Note 5 but for the fact that the approval applied for relates to a product which is materially identical to a product identified in the application and already approved in the UK under the Control of Pesticides Regulations 1986 or the 1995 Regulations in relation to each type of operation covered by the application, and in consequence requires a different type of consideration and checking.”.

(10)    In the Notes (lettered) to the Schedule, after Note E there shall be inserted a new Note F—

“F

Where further information is submitted in response to requests made by the Commission pursuant to Article 6 (4) of the 1991 Directive and the further information is required to be examined and evaluated in order to determine whether an active substance can be added to Annex I to that Directive, then an additional fee under item B(3), based on the size of the data package contained within that information, will become payable as if submission of that information were a resubmitted application.”.

NOTES
Initial Commencement
Specified date

Specified date: 30 November 2002: see reg 1.

3 Transitional provisions

3Transitional provisions

(1)    Subject to paragraphs (2) and (3) these Regulations shall not apply in respect of any application or inspection made before these Regulations come into force.

(2)    The amount of any fee relating to any activity carried out after these Regulations come into force in connection with any application made before they come into force is based on the fee specified in these Regulations.

(3)    The fee for an application and inspection for renewed recognition of a test facility is the fee payable at the time the renewal is due.

NOTES
Initial Commencement
Specified date

Specified date: 30 November 2002: see reg 1.

Signature

Whitty

Parliamentary Under-Secretary,

Department for Environment, Food and Rural Affairs

3rd November 2002

EXPLANATORY NOTE

EXPLANATORY NOTE (This note is not part of the Regulations)

These Regulations extend to Great Britain and amend The Plant Protection Products (Fees) Regulations 2001 (SI 2001/2477) which cover fees to be paid in connection with product approval and related applications resulting from the implementation of Council Directive 91/414/EEC (OJ No L230, 19.8.91 p 1).

The fees for Parallel Import applications are reduced (regulation 2(2) and (3)). An additional numbered Note is added to the Schedule as Note 28 to explain what constitutes a Parallel Import application (regulation 2(9)). A consequential provision is added to Note 5 (Fast applications) in the Schedule (regulation 2(8)). A Fast application is one that calls for technical consideration or label checking, but not significant data examination.

The fees for the inspection for the official recognition of test facilities are increased (regulation 2(5) and (6)). An additional Item C(3) (omitted from the 2001 Regulations but included in their predecessor) has been added to the Table in the Schedule to re-introduce a fee for re-inspections following the first inspections either for an initial or renewed application for official recognition (regulation 2(7)). Re-inspections are carried out when the results of the first inspection do not meet requirements for official recognition.

Where additional information is requested by the EC Commission for examination and evaluation in order to clarify whether a dossier submitted for inclusion of a new active substance in Annex I to the 1991 Directive satisfies the requirements of the Directive then fees can be charged as if that data were treated as a re-submission. The fee will be determined dependent on the size of the data package submitted pursuant to the request (regulation 2(10) as read with regulation 2(4)).

Regulation 3 provides that the Regulations, subject to the exceptions in regulation 3(2) and (3), apply to applications made after the Regulations come into force.

A table of comparison of old and new fees, so far as they are capable of comparison, are set out below:

OLD FEENEW FEE
Parallel Import application (New Item A(2)(i), which was formerly treated as a Fast application under Item A(2)(c))£1,060£710
Parallel Import verification (Item A(4)(c)(iii))£425£300
Initial official recognition of test facility (Item C(1) of the Schedule)£1,120£1,500
Renewed official recognition of test facility (Item C(2) of the Schedule)£840£1,500