Principles and Practice of Pharmaceutical Medicine

possess controlled drugs while acting in their pro-
fessional capacities, and lay down the conditions
under which these activities may be carried out. In
the regulations, drugs are divided into five sche-
dules, each specifying the requirements governing
such activities as import, export, production, sup-
ply possession, prescribing and record keeping
which apply to them:

Schedule 1includes drugs such as cannabis and
lysergide, which are not used medicinally. Pos-
session and supply are prohibited, except in
accordance with Home Office authority.

Schedule 2includes drugs such as diamorphine
(heroin), morphine, pethidine, quinalbarbitone,
glutethimide, amphetamine and cocaine. They
aresubjecttothefullcontrolleddrugrequirements
relating to prescriptions, safe custody (except for
quinalbarbitone),theneedtokeepregistersandso
on (unless exempted in Schedule 5).

Schedule 3includes the barbiturates (except qui-
nalbarbitone, now in Schedule 2), buprenorphine,
diethylproprion, mazindol, meproba- mate, pen-
tazocine, phentermine and temazepam. They are
subject to the special prescription requirements
(except for phenobarbitone and temazepam) but
not to the safe custody requirements (except for
buprenorphine, diethylproprion and temazepam)
nor to the need to keep registers (although there
are requirements for the retention of invoices for
two years).

Schedule 4includes 33 benzodiazepines (tema-
zepam is now in Schedule 3) and pemoline,
which are subject to minimal control. In parti-
cular, controlled drug prescription requirements
do not apply, and they are not subject to safe
custody.

Schedule 5includes those preparations which,
because of their strength, are exempt from vir-
tually all controlled drug requirements other
than retention of invoices for two years.

There is no ‘harmonized’ comprehensive legisla-
tiontocontroldrugsofabuseunderanEUDirective.

33.4 The European controls

of medicinal products

Directive 75/319laid down the legal basis for the

establishment of the Committee on Proprietary

Medicinal Products (CPMP). This met for the

first time in November 1976, at which time there

were nine member states in the EC. Each member

state was represented at the CPMP by its named

representative and specified alternate.

At this time, a procedure was laid down in

Directive 75/318, a scheme for ‘mutual recogni-

tion’ of MAs. Article 9 of this Directive envisaged

that

The member state which has issued a marketing

authorization for a proprietary medicinal product

shall forward to the Committee a dossier containing

a copy of the authorization, together with particulars

and documents specified in Article 4 second para-

graph of Directive 65/65, if the person responsible

has requested the forwarding to at least five other

Member States.

This was later changed to ‘at least two other

member states’ inDirective 83/570to encourage

the use of the procedure, which was initially very

slow in taking off.

This ‘mutual recognition procedure’, initially

called the ‘CPMP procedure’, has had several

other names attached to it, for example the ‘multi-

state procedure’ and the ‘decentralized procedure’.

Manufacturers could choose the country that they

would wish to be the initiating or reference country

to forward their dossier into the multistate proce-

dure. Some countries were more popular than

others (see Table 33.4).

In December 1986, the Council Directive on the

approximation of national measures relating to the

placing on the market of high-technology medic-

inal products, particularly those derived from bio-

technology (87/22/EEC), was published. This

Directive introduced the concept of two classes

of high-technology medicinal product.

Annex A. Medicinal products developed from

the following biotechnological processes:

Recombinant DNA technology.

432 CH33 THE DEVELOPMENT OF HUMAN MEDICINES CONTROL IN EUROPE