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Malta: Implementation of Directive 2001/83/EC as amended 

Category: Malta

Article 1(5) [Definition of homeopathic medicinal product] 

Article 2(1), Medicines Act 2003 (Chapter 458), Medicines (Marketing Authorisation) Regulations 2007 (L.N. 324)

For the purposes of these regulations –

(…)

“homeopathic medicinal product” means any medicinal product prepared from substances called homeopathic stocks in accordance with a homeopathic manufacturing procedure described by the European Pharmacopoeia or, in the absence thereof, by the pharmacopoeias currently used officially in the Member States. A homeopathic medicinal product may contain a number of Principles;

 

Category: Malta

Article 13 [‘Old products’] 

N/A

Category: Malta

Article 14 [Special simplified registration procedure] 

Article 10, Medicines Act 2003 (Chapter 458), Medicines (Marketing Authorisation) Regulations 2007 (L.N. 324)
(1) The Authority shall ensure that homeopathic medicinal products manufactured and placed on the market within the Community are registered or authorised in accordance with regulations 10 and 11. In case of registrations sub-regulations 22(1)(a) to (f) shall apply.
(2) The Authority shall establish a special simplified registration procedure for the homeopathic medicinal products referred to in sub-regulation (3).
(3) Only homeopathic medicinal products which satisfy all of the following conditions may be subject to a special, simplified registration procedure;
(a) they are administered orally or externally;
(b) no specific therapeutic indication appears on the labelling of the medicinal product or in any information relating thereto;
(c) there is a sufficient degree of dilution to guarantee the safety of the medicinal product; in particular, the medicinal product may not contain either more then one part per 10 000 of the mother tincture or more than 1/100th of the smallest dose used in allopathywith regard to active substances whose presence in an allopathic medicinal product results in the obligation to submit a doctor’s prescription.

The classification for the dispensing of the medicinal product, shall be determined by the Authority at the time of registration. The criteria and rules of procedure provided for in regulations 12, 17, 18, 19, 20 and 21. and articles 4(4), 112, 116 and 125 of Directive 2001/83/EC, as amended, shall apply by analogy to the special, simplified registration procedure for homeopathic medicinal products with the exception of the proof of therapeutic efficacy.

Category: Malta

Article 15 [Documents special simplified registration procedure] 

§ 21, USTAWA z dnia 6 września 2001 r. Prawo farmaceutyczne [tekst z uwzględnieniem zmian wprowadzonych ustawą dnia 30 marca 2007 r. o zmianie ustawy – Prawo farmaceutyczne oraz o zmianie niektórych innych ustaw – Dz. U. Nr 75, poz. 492]

(…)

2. Wniosek o dopuszczenie do obrotu produktów, o których mowa w ust. 1, powinien zawierać w szczególności:

1) nazwę i adres podmiotu odpowiedzialnego, wytwórcy lub importera, u którego następuje zwolnienie serii produktu leczniczego, miejsca wytwarzania, w tym miejsca wytwarzania, gdzie następuje kontrola jego serii, lub miejsca prowadzenia działalności importowej, gdzie następuje kontrola jego serii, oraz numery zezwoleń na wytwarzanie produktu leczniczego lub na import produktu leczniczego;

2) nazwę i adres wytwórcy roztworu macierzystego, z którego ma być wytworzony produkt leczniczy homeopatyczny;

3) nazwę naukową lub farmakopealną produktu, zgodną z nazwą surowca zamieszczoną w Farmakopei Europejskiej lub innych odpowiednich farmakopeach uznawanych w państwach członkowskich Unii Europejskiej, a jeżeli takich nie ma, nazwę potoczną, łącznie z określeniem drogi podania, postaci farmaceutycznej oraz stopnia rozcieńczenia;

4) skład produktu, z uwzględnieniem składników pomocniczych;

5) warunki przechowywania i transportu;

6) wielkość i rodzaj opakowania oraz zawartość produktu leczniczego homeopatycznego w opakowaniu bezpośrednim.

3. Do wniosku, o którym mowa w ust. 2, należy dołączyć:

1) opis sposobu otrzymywania i kontroli substancji pierwotnych oraz potwierdzenie, na podstawie piśmiennictwa, w tym naukowego, ich homeopatycznego zastosowania;

2) opis procesu wytwarzania, w tym opis sposobu rozcieńczania i dynamizacji;

3) opis metod kontroli dla każdej formy farmaceutycznej, w tym badania stabilności i czystości mikrobiologicznej;

3a) wyniki, streszczenia i sprawozdania z badań jakościowych, biologicznych i farmaceutycznych wraz z raportem eksperta;

4) oryginał lub uwierzytelnioną kopię zezwolenia na wytwarzanie produktu leczniczego homeopatycznego; 

5) kopie zezwoleń wydanych w innych krajach;

6) zobowiązanie podmiotu odpowiedzialnego do dostarczenia do kontroli analitycznej próbki roztworu macierzystego, z którego ma być wytworzony produkt, a także próbki produktu końcowego;

7) projekt etykiety lub ulotki;

8) dane dotyczące opakowania bezpośredniego, z podaniem wymagań jakościowych, oraz wzory opakowań bezpośrednich lub zewnętrznych, wielkość opakowania, wraz z podaniem informacji o zawartości produktu leczniczego homeopatycznego w opakowaniu bezpośrednim;

9) termin ważności produktu leczniczego homeopatycznego;

10) dane i ostrzeżenia dotyczące:
                a) warunków przechowywania i transportu,
                b) sposobu stosowania.

(…)

8. Minister właściwy do spraw zdrowia określi, w drodze rozporządzenia, szczegółowy sposób przedstawiania dokumentacji, o której mowa w ust. 2, 3, 5 i 6, uwzględniając w szczególności charakter przedstawianej dokumentacji.

9. Minister właściwy do spraw zdrowia określi, w drodze rozporządzenia, wzory wniosków, o których mowa w ust. 2 i 5, i inne rodzaje dokumentów niż wymienione w ust. 3 i 6, biorąc pod uwagę dane zawarte w ust. 2 i 5.

Category: Malta

Article 16 [Marketing authorisation/Territory specific rules] 

Article 11, Medicines Act 2003 (Chapter 458), Medicines (Marketing Authorisation) Regulations 2007 (L.N. 324)
Homeopathic medicinal products, other than those referred to in regulation 10 (3), shall be authorised and labelled in accordance with regulations 5, 7 and 8.

 

 

Category: Malta

Article 28 & Article 39 [Mutual recognition procedure/Decentralised procedure] 

Article 22, Medicines Act 2003 (Chapter 458), Medicines (Marketing Authorisation) Regulations 2007 (L.N. 324)
(a) With a view to the granting of a marketing authorisation for a medicinal product in more than one Member State, including Malta, an applicant shall submit an application to the Authority, based on a dossier identical to that submitted in the other Member States. The dossier shall contain the information and documents referred to in regulations 5, 7 and 8. The documents submitted shall include a list of Member States concerned by the application. The applicant shall request one Member State to act as “reference Member State” and to prepare an assessment report on the medicinal product in accordance with paragraphs (b) and (c) hereof.
(b) Where the medicinal product has already received a marketing authorisation at the time of application, if Malta is a concerned Member State, the Authority shall recognise the marketing authorisation granted by the reference Member State. To this end, the marketing authorisation holder shall request the reference Member State either to prepare an assessment report on the medicinal product or, if necessary, to update any existing assessment report. If Malta is the reference Member State, the Authority shall prepare or update the assessment report within 90 days of receipt of a valid application. The assessment report together with the approved summary of product characteristics, labelling and package leaflet shall be sent to the concerned Member States and to the applicant.
(c) In cases where the medicinal product has not received a marketing authorisation at the time of application, the applicant shall request the reference Member State to prepare a draft assessment report, a draft summary of product characteristics and a draft of the labelling and package leaflet. If Malta is the Reference Member State, the Authority shall prepare these draft documents within 120 days after receipt of a valid application and shall send them to the concerned Member States and to the applicant.
(d) If Malta is a concerned Member State, within 90 days of receipt of the documents referred to in paragraphs (b) and (c) hereof, the Authority shall approve the assessment report, the summary of product characteristics and the labelling and package leaflet and shall inform the reference Member State accordingly. If Malta is the reference Member State, the Authority shall record the agreement of all parties, close the procedure and inform the applicant accordingly.
(e) The Authority shall adopt a decision in conformity with the approved assessment report, the summary of product characteristics and the labelling and package leaflet as approved, within 30 days after acknowledgement of the agreement.
(f) If, within the period laid down in paragraph (d) hereof, the Authority cannot approve the assessment report, the summary of product characteristics, the labelling and the package leaflet on the grounds of potential serious risk to public health, it shall give a detailed exposition of the reasons for its position to the reference Member State, to the other Member States concerned and to the applicant. The points of disagreement shall be forthwith referred to the coordination group. Within such co-ordination group, the Authority shall use its best endeavours to reach agreement on the action to be taken and it shall allow the applicant the opportunity to make his point of view known orally or in writing. If, within 60 days of the communication of the points of disagreement, all Member States reach an agreement, if Malta is the Reference Member State, the Authority shall record the agreement, close the procedure and inform the applicant accordingly and paragraph (e) hereof shall apply:

Provided that if Member States fail to reach an agreement within the co-ordination group, within such 60-day period, and if the Authority has approved the assessment report, the draft summary of product characteristics and the labelling and package leaflet of the reference Member State, the Authority may, at the request of the applicant, authorise the medicinal product without waiting for the outcome of the procedure laid down in Article 32 of Directive 2001#83#EC as amended by Directive 2004/27/EC. In that event, the authorisation granted shall be without prejudice to the outcome of that procedure.

Category: Malta

Article 68 [Labelling & package leaflet] 

Article 14, Medicinal Products (Labelling and Packaging) Regulations 2005.
(1) Without prejudice to sub-regulation (2) of this regulation, homeopathic medicinal products shall be labeled in accordance with the provisions of these regulations and shall be identified by a reference on their labels, in clear and legible form, to their homeopathic nature.

 

Category: Malta

Article 69 [Labelling & package leaflet] 

Article 14, Medicinal Products (Labelling and Packaging) Regulations 2005.

(…)

(2) In addition to the clear mention of the words “homeopathic medicinal product”, the labelling and, where appropriate, the package insert for the homeopathic medicinal products which have qualified for a special simplified registration procedure referred to in regulation 10 of the Medicines (Marketing Authorisation) Regulations, 2005, shall bear the following, and no other, information;

(a) the scientific name of the stock or stocks followed by the degree of dilution, making use of the symbols of the pharmacopoeia referred to in the definition of a homeopathic medicinal product; if the homeopathic medicinal product is composed of two or more stocks, the scientific names of the stocks on the labelling may be supplemented by an invented name;
(b) name and address of the registration holder and, where appropriate, of the manufacturer;
(c) method of administration and, if necessary, route;
(d) expiry date, in clear terms (month, year);
(e) pharmaceutical form;
(f) contents of the sales presentation;
(g) special storage precautions, if any;
(h) a special warning if necessary for the medicinal product;
(i) manufacturer’s batch number;
(j) registration number;
(k) homeopathic medicinal product without approved therapeutic indications;
(l) a warning advising the user to consult a doctor if the symptoms persist.

Category: Malta

Article 100 [Advertising] 

Article 14, Medicinal Products (Advertising) Regulations 2005.
Advertising of homeopathic medicinal products referred to in regulation 10 (3) of the Medicines (Marketing Authorisation) Regulations, 2005 shall be subject to the provisions of these regulations except regulation 5(1), provided that only the information specified in regulation 13(2) of the Medicinal Products (Labelling and Packaging) Regulations, 2005 may be used in the advertising of such medicinal products.

 

 

Category: Malta