Contents - FIP

precursor to further legal and regulatory changes in not only the European Community
Member States at that time (including, for instance, Germany, the Netherlands and
France 10 ) but also in countries ranging from Britain to, at the opposite end of the earth,
Australia and New Zealand.
In the British context, for instance, the 1968 Medicines Act introduced the concept of
pharmacy (P) medicines, as distinct from prescription only medicines (POMs) and general
sales list (GSL) products, which can legally be sold anywhere. In much of the rest of the
world the GSL and/or P categories remain either unknown or more limited in their application
than in the UK model. In the US the P category has not as yet been introduced,
for example, although as a concept it has recently gained attention increasing support.
By contrast in many EU Members States there are fewer GSL medicines available than is
so in the US and the UK.
In the less industrialised world regulatory progress in the first half of the twentieth
century was more focused on more basic aspects fostering basic pharmaceutical supply
integrity. For example, Tunisia’s first drug-specific laws were introduced in 1942. They
controlled aspects of medical and pharmaceutical promotion, as well as medicines provision.
All finished pharmaceutical products imported or manufactured in Tunisia were
required to undergo a Technical Committee review and to obtain a certificate of approval
from the Ministry of Health before being put onto the market.
South of the Sahara, the existence of Nigerian pharmacies supplying allopathic
medicines in cities such as Lagos to European colonists and limited numbers of African
customers dated back to the 1890s. There the Poisons and Pharmacy Ordinance of 1923
preceded the setting up of the country’s first School of Pharmacy that same decade,
although as previously noted the great majority of people remained dependent on West
African traditional medicine. In east Asia, Singapore in 1931 similarly adopted a Poisons
Ordinance that categorised drugs according to how toxic they were and limited access
accordingly.
10 In the Netherlands a new legal basis for the licensing of pharmaceutical manufacturing and distribution was first
established in 1956. Following that the Medicines Act of 1958 required the Medicines Evaluation Board (MEB) to regulate the
admission of medicines to the Dutch market. But the MEB only started work in earnest in 1963 in the wake of the Thalidomide
disaster. West Germany brought in new regulations on drug safety in 1961. The law there was subsequently revised again to
include strengthened requirements for proof of the quality, efficacy and safety of new drugs.
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