Principles and Practice of Pharmaceutical Medicine

Complex applications require initial committee
referral. Therefore, the procedure takes 180 days; a
full fee is charged for review.
Standard applications are generally reviewed
within 120 days, and only ifissues arise that require
referral to a full committee review will this time-
line be lengthened; the applicant may also be
approached to clarify details of the application.
An initial full fee has to be paid by the applicant;
if the procedure passes without referral to the full
committee, the RAwill refund half of the fee to the
applicant.
A ‘me-too’ application, for a product, which has
analogous products with the classification applied
for already in the market,ishandled asstandard Type
II variation, and the corresponding fee is charged.
After an application has been filed, it is pub-
lished for consultation with interested parties for a
4–6-week period – immediately in case of a stan-
dardapplication (based on the reclassification sum-
mary), or after the committee’s advice for
reclassification, in case of a complex procedure.
The consultation period is not included in the time-
lines for approval.
The documentation necessary for a valid reclas-
sification application is listed below:

Reclassification application form

Reclassification summary – a comprehensive
summary in a set format, which will form part
of the information provided for the public con-
sultation (two pages A4)

Safety and efficacy summary – supporting safety
and where necessary efficacy data

Patient information – full details of leaflets and
labels and an indication of the advertising plans

Training and education – a summary of what
provision has been made for appropriate educa-
tion and training

Clinical expert report – a critical evaluation of
the proposed pharmacy product demonstrating
that none of the prescription criteria (see above)
apply

Crucial issues that must be addressed in the expert

report of the application are the ease of self-diag-

nosis of the target disease, whether the substance is

a narcotic or a psychotropic substance, if there is a

risk of abuse leading to addiction and whether the

substance has a potential for misuse for illegal

purposes.

If the maximum dose is restricted when the

medicine is supplied P or GSL to protect against

adverse effects from correct or incorrect use of the

medication, it is important to prove that the

restricted dose is still as effective and keeps the

same benefit–risk relationship, as the original full

dose.

GSL can be considered for those medicines

which can, with reasonable safety, be sold or sup-

plied without the supervision of a pharmacist. The

following classes of products are excluded from

GSL:

Anthelmintics

Parenterals

Eye drops

Eye ointments

Enemas

Irrigations used wholly or mainly for wounds,

bladder, vagina or rectum

Aspirin or aloxiprin for administration wholly or

mainly to children

Product recall

The GMP Directive requires each manufacturer to

have a system for complaints and product recall

readily in place. Section 8 of the Directive

requires review of any complaint about potentially

defective products following a written procedure

and if necessary the effective and prompt recall of

defective products from the market. It is a require-

ment to inform the QP and the quality control

department during the review and analysis of all

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