Ministry of Health
Decree — Official Gazette n.249 of
Update of the tables containing the indication of narcotic and psychotropic substances of which al decree del President of the Republic 9 October 1990, n. 309, e next modifications and integrations. Inclusion in Table I of the substance tramadol.Insertion of the tramadol between i medicinal products di which Annex IIIa and the table of medicinal products section A. Insertion tramadol in the table of medicinal products section D ‘COMPOSITIONS for administrations other than parenteral use»
THE MINISTER OF HEALTH
Having regard to Articles 2, 13 and 14, 43 comma 4-bis, del decree del
President of the Republic 9 October 1990, n. 309, e next
modifications bearing: ‘Text unique of read in matter di
regulation of narcotic drugs and psychotropic substances and prevention,
care and rehabilitation of related states di drug addiction’, di
hereinafter referred to as the ‘single text’;
Having regard to the classification of narcotic substances e psychotropic
in five tables named Table I, II, III and IV e Table of
medicines, divided into five sections indicated by the letters A, B,
C, D and E, where they are distributed i medicinal products in conformity ai
criteria for the formation of the Tables referred to in art.14 del text
unique, e the Annex III-bis, that includes i medicines that
benefit from simplified prescriptive modalities per la therapy
of pain;
Seen, in particular, art. 14, paragraph 1, letters a), e) ed h),
concerning the criteria for the formation of Table I e della Table
of medicinal products, Section A and Section D;
Having regard to the law of 15 March 2010, n. 38, bearing provisions to ensure access to palliative care and pain therapy;
Considering that tramadol is a synthetic opioid, that
constitutes the principle active di drugs painkillers of
class of opioids, which to date is not present in the tables di
referred to in the Decree of the President of the Republic n.309/1990;
Taking into account that medicinal products for human use and for use
veterinarian in trade a base di tramadol report such as
therapeutic indications: acute and chronic painful states of media e
severe intensity, such as pain post-surgical, pain da trauma,
pain pertaining to oncology and which are also present medicinal products
containing tramadol in combination with other substances, quali IL
, for the treatment of moderate acute pain;
Taking into account that at the end of the 41st meeting of the Expert Committee
on Drug Dependence (ECDD), which was held in Geneva since 12 al 16
November 2018, the recommendation of   was expressed; keep under
surveillance of tramadol-based medicinal products;
Given the notes prot.SNAP 8/19 of April 4, 2019 and SNAP 28/19 of 17
September 2019 received from the Unit di coordination del
National system di alert early del Department policies
anti-drugs of the Presidency of the Council of Ministers, concerning
alerts of II degree relative a four cases di intoxication
associated with the consumption of tramadol (of which three in subjects abusers
of new psychoactive substances) on the national territory, in period
July 2018 — April 2019;
Considering that the Italian Medicines Agency (AIFA), in follow-up
to the opinion of the Technical Scientific Commission (CTS) delivered In the
sitting of the 11th, he arranged for I holders di A.I.C.
that all medicinal products available to the general public, with the exception of
packs for hospital use only, containing a opioid in
any pharmaceutical form, must indicate on the outer label,
so well visible, le following information enclosed in a
rectangle from color border red, how described in follow-up:
«Contains opioid.It can be addictive.’;
Acquired the opinion of the Higher Institute of health, return with
note del 4 August 2020 e del 23 December 2021, favourable
to include tramadol in Table I of the single text as well as ‘
the inclusion of tramadol among i medicinal products di which annex
III-bis of the Decree of the President of the Republic n. 309/90, with
insertion del tramadol in section A della Table of
medicinal products, and tramadol compositions for administration ad use
other than parenteral in section D of the same table,
marked with double asterisk (**), relative alle modalities
simplified prescriptive in pain therapy;
Having obtained the opinion of the Superior Council of Health, section V,
expressed at sittings of e del 12 April 2022,
in favour of including tramadol in Table I del text
unique as well as the inclusion of tramadol among i medicinal products di which
in Annex III-bis to the Decree of the President of Republic n.
309/1990, with inclusion of tramadol in section A of Table
of medicinal products, and tramadol compositions for administration ad
non-parenteral use in section D della same
table, marked with double asterisk (**), relative alle
simplified prescriptive modalities in pain therapy;
Deemed necessary proceed to inclusion del tramadol in
Table I of the consolidated text, to protect access to the cure e of
public health, also in view of cases of intoxication and
seizures reported on the national territory as well as ‘ the inclusion
of tramadol in the list of medicinal products in the Annex III-bis
and the updating of the Table of Medicinal Products Section A e section
D;
Considering that the Italian Medicines Agency (AIFA), with note of
, has retained di dover predict a timing
adequate to implementation of measures related alla new
classification of tramadol by the companies concerned, in order to avoid possible deficiencies due a delays in the application del
present decree;
Decree:
Art.1
1. In Table I of the President’s decree della Republic 9
October 1990, n. 309, e next modifications, e’ inserted,
second the order alphabetical, la next substance: Tramadol
(common name).
Art. 2
1. In the Annex III-bis del decree del President della
Repubblica 9 October 1990, n.309, e next modifications,
inserted ‘Tramadol’ in alphabetical order.
2. In the Table dei medicines, section A, del decree del
President of the Republic 9 October 1990, n. 309, e next
modifications, is inserted, marked with a double asterisk (**),
indicating medicines included in the Annex III-bis, used
in therapy del pain, second the order alphabetical, il
«Tramadol**».
3. In the Table dei medicines, section D, del decree del
President of the Republic 9 October 1990, n. 309, e next
modifications, is inserted, marked with a double asterisk (**),
indicating medicines included in the Annex III-bis, used
in therapy del pain, in section «Compositions for
administrations ad use different da that parenteral’, according to
the alphabetical order, the ‘Tramadol**’.
Art.3
1. Persons authorised to manufacture, use, distribute and
dispense of tramadol and human and veterinary medicinal products (based on
tramadol) shall be required to implement all le measures forecast from
legislation in force for tabulated substances, in accordance with a quantum
established in present decree, within the term di months You are
from the entry into force of this decree.
The present decree entra in vigor the fifteenth day
following its publication in the Gazette Official
of the Italian Republic.
Rome,
The Minister: Hope
— Reproduction reserved and for personal use
Access to the site is restricted and reserved for healthcare professionals
You have reached the maximum number of visits