Medicines (Clinical
Trial Exemptions) (No. 2) (Jersey)
Order 1997[1]
THE HEALTH AND SOCIAL SERVICES COMMITTEE in pursuance of Articles 14, 16, 36 and 110 of the Medicines (Jersey)
Law 1995, after consultation with the Medicines Advisory Council and
having otherwise complied with Article 110 of the Law, orders as
follows –
Commencement [see endnotes]
1 Interpretation
(1) In
this Order, unless the context otherwise requires –
“control product”,
in respect of a clinical trial of which the primary object is to assess the
effects (if any) of a medicinal product, means a substance or article that is
administered by way of the trial in order that any effects of the substance or article
may be compared with any effects of the medicinal product;
“Law” means
the Medicines (Jersey)
Law 1995.
(2) Without
prejudice to Article 10 of the Interpretation (Jersey)
Law 1954, every provision in the Medicines (Jersey)
Law 1995 that relates in any other way to its
interpretation shall also apply in the same way to this Order, unless the
context otherwise requires.
2 Exemption of medicinal products for clinical trials
(1) This Article applies
only to the following medicinal products –
(a) a
medicinal product that is manufactured in accordance with a product licence;
(b) a
medicinal product that is manufactured in accordance with a product licence but
for a change carried out in the course of manufacture, where that change has
been approved by the Minister for the purposes of this Order;
(c) in
particular, but without limiting the generality of sub-paragraph (b), a
medicinal product that is manufactured in accordance with a product licence but
for the shape or colour of the product or the omission from it of a distinctive
mark to be displayed on it, where the change in shape or colour or the omission
of the mark –
(i) has been made by
or to the order of the holder of the product licence, and
(ii) has
been approved by the Minister for the purposes of this Order; and
(d) a
medicinal product in respect of which there is in force a product licence, and
which for the purposes of its administration in the course of a clinical trial
is enclosed in or surrounded by inert substances –
(i) by or to the order
of the holder of the product licence, and
(ii) with
the approval of the Minister for the purposes of this Order.
(2) Subject to Article 6
of this Order, the restrictions in Articles 8 and 32 of the Law shall
not apply to –
(a) the
selling or supplying;
(b) the
procuring of the sale, supply, manufacture or assembly; or
(c) the
importing,
of a medicinal product for the purposes of a clinical trial, where
the conditions in paragraph (3) or the alternative conditions in paragraph (4)
are fulfilled.
(3) The conditions to which
paragraph (2) refers are –
(a) the
medicinal product is administered in accordance with the particulars of the
product licence that relate –
(i) to indications
for which the product is to be administered,
(ii) to
the dosage, and the methods and routes of administration, and
(iii) in
respect of any directions, to contra-indications or warnings contained in the
product licence;
(b) the
provisions of the product licence relating to manufacture, testing and
maintenance of records of adverse reactions and effects are complied with
(except, in respect of manufacture, to the extent described in paragraph (1)(c));
and
(c) where
the clinical trial is to be carried out under arrangements made by or at the
request of a person who is not the holder of the product licence, that
person –
(i) informs the
Minister of the trial, and
(ii) makes
arrangements that are in the opinion of the Minister adequate for informing the
Minister of any adverse reactions, adverse effects, unexplained absences of
effects and unexpected absences of effects that are in any such case associated
with the administration of the product.
(4) The alternative
conditions to which paragraph (2) refers are –
(a) the person
proposing to sell or supply the medicinal product, or to procure its sale,
supply, manufacture or assembly, or to import it, has informed the Minister of
the proposed activity, and has furnished details of the clinical trial; and
(b) the
Minister has directed that this Article shall apply to the activity.
3 United
Kingdom Exemption of medicinal products for clinical trials[2]
(1) The restrictions in
Articles 8 and 32 of the Law shall not apply to the selling, supplying or
importing, or the procuring of the sale, supply, manufacture or assembly, of a
medicinal product for the purposes of a clinical trial where the restrictions
imposed by sections 7 and 31 of the Medicines Act 1968 of the United
Kingdom do not apply to the medicinal product by virtue of Article 2 of
the Medicines (Exemption from Licences) (Clinical Trials) Order 1974 of
the United Kingdom.
(2) Any conditions
applicable to the exemption conferred by Article 2 of the Medicines
(Exemption from Licences) (Clinical Trials) Order 1974 of the United
Kingdom shall be applicable to the exemption conferred by paragraph 1 of this
Article.
(3) If an exemption
conferred by Article 2 of the Medicines (Exemption from Licences)
(Clinical Trials) Order 1974 of the United Kingdom shall cease to apply by
virtue of a withdrawal of notification under Article 4(2) of that Order,
the exemption conferred by paragraph (1) of this Article shall forthwith
cease to have effect.
4 Exemption of control products for clinical trials
(1) This Article applies
only where each medicinal product (other than a control product) that is to be
administered in the course of a clinical trial is –
(a) a
product in respect of which the exemption conferred by Article 2 of this Order
applies; or
(b) a
product in respect of which the condition in Article 32(3)(a) of the Law
is fulfilled.
(2) Subject to Article 6
of this Order, the restrictions in Articles 8 and 32 of the Law shall not
apply to –
(a) the
selling or supplying;
(b) the
procuring of the sale, supply, manufacture or assembly; or
(c) the
importing,
of a medicinal product that is a control product, for the purposes
of a clinical trial, where the conditions in any of sub-paragraphs (a),
(b), (c) and (d) of paragraph (3) of this Article are fulfilled.
(3) The conditions to which
paragraph (2) refers are –
(a) the
specification of each control product has been included in a clinical trial
certificate (whether or not the certificate is in force) issued in respect of a
clinical trial other than the trial in question and relating to medicinal
products of the same description as the medicinal product that is to be
administered in the course of the trial in question, and –
(i) that control
product is to be administered in accordance with that certificate, or
(ii) the
Minister has been informed of the proposed administration of that control
product and has not directed that the provisions of this Article shall not
apply to it;
(b) the
composition and specification of each control product and of the other
medicinal products to be administered in the course of the trial in question
are identical, except for the omission from the control product of any active ingredient
or ingredients;
(c) each
control product consists only of ingredients that are not active ingredients,
and are ingredients –
(i) that have been
approved by the Minister for the purposes of this Order, or
(ii) that
correspond to ingredients contained in the other medicinal products to be
administered in the course of the trial in question; or
(d) the person
proposing to sell or supply the control product, or to procure its sale,
supply, manufacture or assembly, or to import it, has informed the Minister of
the proposed activity and has furnished details of the clinical trial in
question, and the Minister has directed that this Article shall apply to the
activity.
5 United
Kingdom Exemption of control products for clinical trials[3]
(1) The restrictions in
Articles 8 and 32 of the Law shall not apply to the selling, supplying or
importing, or the procuring of the sale, supply, manufacture or assembly of a medicinal product that is a control
product, for the purposes of a clinical trial where the restrictions imposed by
sections 7 and 31 of the Medicines Act 1968 of the United Kingdom do not
apply to the medicinal product that is a control product by virtue of Article 3
of the Medicines (Exemption from Licences) (Clinical Trials) Order 1974 of
the United Kingdom.
(2) Any conditions
applicable to the exemption conferred by Article 3 of the Medicines
(Exemption from Licences) (Clinical Trials) Order 1974 of the United
Kingdom shall be applicable to the exemption conferred by paragraph (1) of
this Article.
(3) If an exemption
conferred by Article 3 of the Medicines (Exemption from Licences)
(Clinical Trials) Order 1974 of the United Kingdom shall cease to apply by
virtue of a withdrawal of a notification under Article 4(2) of that Order,
the exemption conferred by paragraph (1) of this Article shall forthwith
cease to have effect.
6 Restrictions on exemptions of vaccine, plasma and serum
(1) An exemption conferred
by Article 2 or 4 shall not apply to any vaccine, plasma or serum unless
the Minister has been informed of the clinical trial in question.
(2) An exemption conferred
by Article 2 or 4 shall not apply to any vaccine, plasma or serum
if –
(a) the
Minister is of the opinion that in the interests of safety the exemption should
not apply to that vaccine, plasma or serum;
(b) the
Minister has so notified the person seeking the benefit of the exemption; and
(c) the
Minister has not withdrawn its notification.
7 Citation
This Order may be cited as the Medicines (Clinical Trial Exemptions)
(No. 2) (Jersey) Order 1997.