IDRAC 80326

IDRAC COMPARATIVE TABLE

COMPASSIONATE USE

Recent Document Updates Date Updated Sections

Update in progress Sweden
Minor Edit* May-2010
Minor Edit* Mar-2010
Minor Edit* Nov-2009
Law 63/2009 (IDRAC 94359): Amending the Drug
Law, the Law on Safety of Tissues, the Law on
Importation of Medicinal Products 2002 and the Law
Aug-2009 Austria
Establishing the Austrian Agency For Health and Food
Safety, the Federal Office For Food Safety and the
Federal Office For Health Care Safety
Article 40.3.c. of the Medicines Law (IDRAC 64988) Jul-2009 Netherlands
Minor Edit* Mar-2009
* Minor Edit = grammar edit or minor wording change including updated IDRAC-links

According to Art. 5 Directive 2001/83/EC (IDRAC 37421) of 06-Nov-2001, EU Member States may, in
accordance with legislation in force and to fulfill special needs, allow the supply of unauthorized
medicinal products in response to a bona fide unsolicited order, formulated in accordance with the
specifications of an authorized health-care professional and for use by an individual patient under his
direct personal responsibility.

This table is intended to provide information on Compassionate Use for each Member State. In
particular, the column on Compassionate use programs shows which of the three EU programs for
compassionate use: named-patient, cohort or hospital site, are possible in the country.

For more information click the hyperlinks provided on the name of each country. The hyperlinks lead to
the explanatory document on Compassionate Use when available.

1. EU Member States

Is
compassionate Compassionate
Country Legal Basis Guidance document
use regulated use programs
in the country?
EMEA/27170/2006:
Guideline on Named-patient
Regulation
EU YES Compassionate Use in Cohort
726/2004/EC
the European Hospital site
Community
8a. (1) to (4): Named-patient
Austria
YES Medicinal Products EU Guideline applies Cohort
Act Hospital site

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 IDRAC 80326

Is
compassionate Compassionate
Country Legal Basis Guidance document
use regulated use programs
in the country?
Royal Order of 14-
Belgium YES / Named patient
Dec-2006
Bulgaria
YES1 / EU Guideline applies /
Not covered by Not covered by Not covered by
Cyprus Not covered by IDRAC
IDRAC IDRAC IDRAC
Czech
Law 378/2007 (Par.
Republic YES2 / /
41)
Guideline for
Application to
Distribute Non-
Marketed Medicinal
Named patient
Medicinal Product Act Products for a Named
Denmark YES Cohort
No 1180 Patient and
Hospital site
Information note on
distribution of non-
marketed products

Named patient
Estonia YES Medicinal Product Act / Cohort
Hospital site
Medicinal Product Act Medicinal Products Named patient
Finland YES No 395/1987 Ordinance No Cohort
693/1987 Hospital site
Code of Public Health
(Art. L.5121-12 and
Notice to Applicants
France YES from R.5121-68 to /
for ATU
R.5121-76)

Named patient
14th Amendment of
Germany YES 3
Cohort
the Drug Law
Hospital site
Ministerial Decree
YES
3/..
Greece / /
86209/09

Act XCV/2005:
Hungary YES "Medicines Act" / Named patient
Decree No 44/2004
Ireland
NO4 / / /
Ministerial Decree
Italy YES 08-May-2003 / /

1
Bulgaria: Partially implemented, an Ordinance shall be published upon Art. 9 of the Law LMPHM of 13-Apr-2007
2
Czech Republic: Specific therapeutic programmes apply in these cases
3
Germany: No guidance document available. The provision for comp. use is in the German Drug Law but a process/procedure
has not yet been established a decree is pending.
4
Ireland: The wholesaler supplying the unlicensed product has to advise the IMB

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 IDRAC 80326

Is
compassionate Compassionate
Country Legal Basis Guidance document
use regulated use programs
in the country?
Pharmaceutical Law
Latvia YES (Section 5-3 and 19) / /
Regulations No 436
NO
Lithuania / / /
Not covered by Not covered by Not covered by
Luxembourg Not covered by IDRAC
IDRAC IDRAC IDRAC
Not covered by Not covered by Not covered by
Malta Not covered by IDRAC
IDRAC IDRAC IDRAC
Article 3.17 and 3.18
Article 40.3.c. of the
of the Regulation /
Netherlands YES Medicines Law
Medicines Law (IDRAC
(IDRAC 64988)
73855)
/
Poland NO / /
Decree-Law
Deliberation Named patient
Portugal YES 176/2006
105/CA/2007 Hospital site
Order 962/2006
Romania YES Law No 95/2006 / Named patient
(Art. 699-1)
Named patient
Law 140/98 as
Slovakia YES / Cohort
amended
/
Slovenia YES5 / /
Law 29/2006 (Art.
24) and Royal
Spain YES Decree 223/2004 / Named patient
(Art. 28), Royal
Decree 1015/2009
Named patient
Sweden YES LVFS 2008:1 / Cohort
Hospital site
United Named patient
YES SI 1994 No 3144 MHRA Guidance No 14
Kingdom

2. Non EU Member States

Is
compassionate Compassionate
Country Legal Basis Guidance document
use regulated use programs
in the country?
Not covered by Not covered by Not covered by
Iceland Not covered by IDRAC
IDRAC IDRAC IDRAC
Named patient
Provision FOR-1999-
Norway YES Guidelines Jun-2006 Cohort
12-22-1559
Hospital site

5
Slovenia: Compassionate Use is now in practice for palliative care to administer registered medicinal products

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 IDRAC 80326

Is
compassionate Compassionate
Country Legal Basis Guidance document
use regulated use programs
in the country?
Explanatory Note:
Authorization for the
Use and the Import of
Law on Therapeutic Unauthorized
Switzerland YES /
Products Preparation in
Switzerland ("Special
Authorization")
(BW107_00_001)
Ukraine Not available Not available Not available Not available

3. Candidate Member States

Is
compassionate Compassionate
Country Legal Basis Guidance document
use regulated use programs
in the country?
The Act on
Amendment to the
Croatia YES / /
Health Care Act, 13-
Jul-2006
IEGM Guideline:
Turkey YES / Compassionate Use Named patient
Programme

Source: IDRAC

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