Traditionally, the Danish health authorities approve drugs, and the observation of GMP-rules is based on an open dialogue with the producing companies.
Also read about some of the most important permits and authorizations that must be obtained.
Approval of Drugs
Traditionally, the Danish health authorities approve drugs, and
the observation of GMP-rules is based on an open dialogue with the
producing companies.
The authorities have a pragmatic approach to disputed points and
an openness towards the industry’s input, which contributes to
professional discussions all the way through.
The drug manufacturer will be linked up with a dedicated drug
inspector who will receive all requests regarding disputed points
concerning GMP-related matters and registration. In many cases, the
request can be settled by phone – more complicated questions in
writing.
In EU, a formalised collaboration exists between the European
countries’ drug inspectorates, and here Denmark plays a very active
role in the development and interpretation of EU’s GMP-rules.
Denmark is thus up front when it comes to knowledge of the trends
and possible developments within the GMP-area – a position from
which the industry benefits in the collaboration with the
inspectors.
Legislation in Denmark
Pharmaceutical companies are required to apply for permits and
authorizations from various authorities. The companies, however,
generally meet a flexible and efficient administration.
The municipalities in the area are very favourable towards trade
and industry, and it is tradition to create trustworthy
collaborations between companies and public administration.
The following are some of the most important permits and
authorizations that must be obtained.
Environmental Permits
Before obtaining a building permit, a pharmaceutical facility is
required to obtain an environmental permit through an environmental
application.
Approval time is typically 9-12 months, and approval is normally
effected in a co-operation between the pharmaceutical company and
the engineering company.
Building Permits
Before starting excavations, the project requires a building
permit.
After construction, the facility is inspected and approved by the
Building and Fire Inspector and the Health and Safety Department
for the issuing of an occupancy permit.
Manufacturing Authorization
After establishment, qualification and validation of a new
pharmaceutical facility, the facility is inspected and approved by
the health authorities for the issuing of a manufacturing
authorization.
The manufacturing authorization is obtained by submitting a
master file to the authorities, which then inspect the
facility.
Find more information in the brochure “Biopharmaceutical
facilities”
here.
